Intrathecal Baclofen Therapy in Patients With Multiple Sclerosis: Improved Outcomes and Reduced Costs Through Identification of Catheter Malfunction.

INTRODUCTION: Two patients previously implanted with intrathecal Baclofen (ITB) pumps for management of intractable spasticity due to multiple sclerosis (MS) were referred to our center for ongoing management of their spasticity. Initial evaluation of these patients revealed high levels of spasticity in the presence of ITB doses 10 times the average daily dose of our other MS patients. CLINICAL FACTS: High doses of ITB required frequent clinical visits and result in high drug and procedure costs. Both patients' daily doses were greater than 1000 mcg/day resulting in clinical visits every 1-2 months with drug and procedure costs ranging from 16 to 23 thousand dollars annually based on Medicare national average pricing for physician's office. Of the 59 MS patients receiving ITB therapy at our institution, the mean, median, and mode daily doses for ITB are 184, 115, and 159 mcg/day, respectively. The high ITB doses in these patients and poor spasticity control raised suspicion for pump/catheter malfunction and prompted immediate troubleshooting. FINDINGS: One patient's catheter was found to be disconnected from the pump and the other's catheter tip was outside the intrathecal space. In both cases, the patients were not receiving the therapy. After pump/catheter replacement, both patients received excellent clinical benefits from ITB at significantly lower daily doses. This reduction in dose resulted in decreased frequency of medication refills (twice annually) which resulted in decreased cost of care (12-19 thousand dollars savings annually per patient). DISCUSSION: These cases illustrate the need for early ITB pump troubleshooting to identify catheter problems, improve efficacy, and avoid unnecessary healthcare costs.

Injury and Liability Associated with Implantable Devices for Chronic Pain.

BACKGROUND: Due to an increase in implantable device-related anesthesia pain medicine claims, the authors investigated anesthesia liability associated with these devices. METHODS: After institutional review board approval, the authors identified 148 pain medicine device claims from 1990 or later in the Anesthesia Closed Claims Project Database. Device-related damaging events included medication administration events, infections, hematomas, retained catheter fragments, cerebrospinal fluid leaks, cord or cauda equina trauma, device placed at wrong level, stimulator incorrectly programmed, delay in recognition of granuloma formation, and other issues. RESULTS: The most common devices were implantable drug delivery systems (IDDS; 64%) and spinal cord stimulators (29%). Device-related care consisted of surgical device procedures (n = 107) and IDDS maintenance (n = 41). Severity of injury was greater in IDDS maintenance claims (56% death or severe permanent injury) than in surgical device procedures (26%, P < 0.001). Death and brain damage in IDDS maintenance claims resulted from medication administration errors (n = 13; 32%); spinal cord injury resulted from delayed recognition of granuloma formation (n = 9; 22%). The most common damaging events for surgical device procedures were infections, inadequate pain relief, cord trauma, retained catheter fragments, and subcutaneous hygroma. Care was more commonly assessed as less than appropriate (78%) and payments more common (63%) in IDDS maintenance than in surgical device procedure claims (P < 0.001). CONCLUSIONS: Half of IDDS maintenance claims were associated with death or permanent severe injury, most commonly from medication errors or failure to recognize progressive neurologic deterioration. Practitioners implanting or managing devices for chronic pain should exercise caution in these areas to minimize patient harm.

Intrathecal Morphine Infusion Therapy in Management of Chronic Pain: Present and Future Implementation in Korea.

PURPOSE: Intrathecal morphine pump (ITMP) infusion therapy is efficient in managing malignant and nonmalignant chronic pain refractory to standard treatment. However, the high cost of an ITMP is the greatest barrier for starting a patient on ITMP infusion therapy. Using the revised Korean reimbursement guidelines, we investigated the cost effectiveness of ITMP infusion therapy and conducted a patient survey. MATERIALS AND METHODS: A retrospective chart review of 12 patients who underwent ITMP implantation was performed. Morphine dose escalation rates were calculated, and numeric rating scale (NRS) scores were compared before and after ITMP implantation. We surveyed patients who were already using an ITMP as well as those who were candidates for an ITMP. All survey data were collected through in-person interviews over 3 months. Data on the cost of medical treatment were collected and projected over time. RESULTS: The NRS score decreased during the follow-up period. The median morphine dose increased by 36.9% over the first year, and the median time required to reach a financial break-even point was 24.2 months. Patients were more satisfied with the efficacy of ITMP infusion therapy than with conventional therapy. The expected cost of ITMP implantation was KRW 4000000-5000000 in more than half of ITMP candidates scheduled to undergo implantation. CONCLUSION: The high cost of initiating ITMP infusion therapy is challenging; however, the present results may encourage more patients to consider ITMP therapy.

Health Services Utilization and Payments in Patients With Cancer Pain: A Comparison of Intrathecal Drug Delivery vs. Conventional Medical Management.

INTRODUCTION: To compare health services utilization and payments for cancer patients who received an implantable intrathecal drug delivery (IDD) system, consisting of a pump and catheter, vs. conventional medical management (CMM) for the treatment of cancer-related pain. METHODS: This retrospective claims-data analysis compared health services utilization and payments in a population of patients receiving either IDD or CMM for treatment of cancer pain. Patients were propensity score-matched 1:1 based on characteristics including, but not limited to, age, gender, cancer type, comorbid conditions, and health care utilization and payments. RESULTS: From a sample of 142 IDD patients and 3188 CMM patients who met all inclusion/exclusion criteria, 73 matched pairs were obtained. In the year following implant, IDD patients had a consistent trend of lower medical utilization, and total payments that were $3195 lower compared to CMM. CONCLUSIONS: Despite the high initial cost of IDD, this analysis suggests that patients with IDD incur lower medical utilization and payments over the first year post-implant. Further analysis comprised of a larger, longitudinal sample would contribute to health economics and outcomes research, and assist with future practice guideline development.

Intrathecal Morphine Infusion Therapy in Management of Chronic Pain: Present and Future Implementation in Korea

PURPOSE: Intrathecal morphine pump (ITMP) infusion therapy is efficient in managing malignant and nonmalignant chronic pain refractory to standard treatment. However, the high cost of an ITMP is the greatest barrier for starting a patient on ITMP infusion therapy. Using the revised Korean reimbursement guidelines, we investigated the cost effectiveness of ITMP infusion therapy and conducted a patient survey. MATERIALS AND METHODS: A retrospective chart review of 12 patients who underwent ITMP implantation was performed. Morphine dose escalation rates were calculated, and numeric rating scale (NRS) scores were compared before and after ITMP implantation. We surveyed patients who were already using an ITMP as well as those who were candidates for an ITMP. All survey data were collected through in-person interviews over 3 months. Data on the cost of medical treatment were collected and projected over time. RESULTS: The NRS score decreased during the follow-up period. The median morphine dose increased by 36.9% over the first year, and the median time required to reach a financial break-even point was 24.2 months. Patients were more satisfied with the efficacy of ITMP infusion therapy than with conventional therapy. The expected cost of ITMP implantation was KRW 4000000-5000000 in more than half of ITMP candidates scheduled to undergo implantation. CONCLUSION: The high cost of initiating ITMP infusion therapy is challenging; however, the present results may encourage more patients to consider ITMP therapy.

Cost-Effectiveness of Immediate Compared With Delayed Postpartum Etonogestrel Implant Insertion.

OBJECTIVE: To evaluate the cost-effectiveness of immediate compared with delayed (6 weeks) postpartum etonogestrel implant insertion in preventing future unintended pregnancy. METHODS: We constructed a decision-analytic model to examine a hypothetical population of women who request a contraceptive implant after giving birth. The timeframe for analysis was from the time of childbirth to 1 year postpartum. Model inputs were derived from a comprehensive literature review. We compared immediate (before discharge from the childbirth hospital stay) compared with delayed (at first postpartum office visit) postpartum placement of the contraceptive implant from a health care system's perspective. Implant insertion and removal, loss to follow-up at the postpartum visit, use of alternative contraceptive methods, and contraceptive failure were incorporated into the model. We calculated the incremental cost of immediate insertion for each pregnancy prevented during the first postpartum year and cost savings associated with pregnancies prevented. One-way sensitivity analyses were also performed. Cost estimates are reported in 2014 U.S. dollars. RESULTS: Immediate postpartum implant insertion is associated with higher expected cost than delayed insertion ($1,091/patient compared with $650/patient) but is more effective in preventing pregnancies (expected pregnancy rate: 2.4% and 21.6%, respectively). This results in an incremental cost-effectiveness ratio of $2,304 per pregnancy prevented. When taking into consideration medical costs of the resulting unintended pregnancies that could be avoided, immediate implant insertion is expected to save $1,263 per patient. CONCLUSION: Immediate postpartum provision of the contraceptive implant is cost-effective in preventing unintended pregnancies and should be provided to women requesting this form of contraception.

Longevity and cost of implantable intrathecal drug delivery systems for chronic pain management: a retrospective analysis of 365 patients.

OBJECTIVES: Intrathecal drug delivery systems represent an important component of interventional strategies for refractory chronic pain syndromes. Continuous intrathecal administration of opioids results in higher subarachnoid drug concentrations, improved pain scores, and less frequent side effects when compared with systemic opioid administration. Substantial costs arise at the time of surgical implantation and at revision for battery depletion or treatment of a complication. Despite current widespread use, the real-world longevity and cost of implanted intrathecal pumps (ITP) has not been fully quantified. MATERIALS AND METHODS: Patients with an ITP implanted at Cleveland Clinic Pain Management Center between January 1998 and December 2012 were included. ITP longevity was calculated as the time between implant and explant for depletion of the system's battery. Using the 2013 fee schedule of the Centers for Medicare & Medicaid Services, the daily cost of having a functioning ITP was calculated. The costs of office visits for pump refills and the cost of intrathecal medications were not included, nor were the possible savings due to decreased utilization of alternate medical services. RESULTS: Three hundred sixty-five patients had 559 pumps implanted. Postlaminectomy syndrome was the most common indication (40%). The median system longevity for all pumps was 5.4 years (97.5% confidence interval: [5.0, 5.8]), including pumps extracted prematurely, as well as those that reached the elective replacement interval. The median ITP longevity was 5.9 years (95% confidence interval: [5.6, 6.1]) for pumps explanted for end of battery life. The median system cost per day was $10.46. The median cost per day of pumps explanted for end of battery life was $9.26, versus $44.59 for pumps explanted prematurely due to complications. CONCLUSIONS: Overall, the cohort experienced an increased incidence of pump-related complications and a device longevity that was within the range of the manufacturer's anticipated lifespan. Increasing the lifespan of the ITP and improving patient selection have the potential to significantly improve the cost-effectiveness of intrathecal therapy.

Cost effectiveness of different central venous approaches for port placement and use in adult oncology patients: evidence from a randomized three-arm trial.

BACKGROUND: No randomized trials have so far investigated the cost effectiveness of different methods for implantation and use of central venous ports in oncology patients. PATIENTS AND METHODS: Overall, 403 patients eligible for receiving intravenous chemotherapy for solid tumours were randomly assigned to implantation of a single type of port, either through a percutaneous landmark access to the internal jugular vein, an ultrasound (US)-guided access to the subclavian vein, or a surgical cut-down access through the cephalic vein at the deltoid-pectoralis groove. Insertion and maintenance costs were estimated by obtaining the charges for an average implant and use, while the costs of the management of complications were analytically assessed. The total cost was defined as the purchase cost plus the insertion cost plus the maintenance cost plus the cost of treatment of the complications, if any. RESULTS: A total of 401 patients were evaluable-132 with the internal jugular vein, 136 with the subclavian vein and 133 with the cephalic vein access. No differences were found for the rate of early complications. The US-guided subclavian insertion site had significantly lower failures. Infections occurred in 1, 3, and 3 patients (internal jugular, subclavian, and cephalic access, respectively; p = 0.464), whereas venous thrombosis was observed in 15, 8, and 11 patients, respectively (p = 0.272). Mean cost for purchase, implantation, diagnosis and treatment of complications in each patient was 2,167.85 for subclavian US-guided, 2,335.87 for cephalic, and 2,384.10 for internal jugular access, respectively (p = 0.0001). CONCLUSION: US real-time guidance to the subclavian vein resulted in the most cost-effective method of central venous port placement and use.

Medical cost impact of intrathecal drug delivery for noncancer pain.

INTRODUCTION: As healthcare budgets continue to contract, there is increased payer scrutiny on the use of implantable intrathecal drug-infusion devices. This study utilizes claims data to evaluate the economic effects of intrathecal drug delivery (IDD) based on health services utilization and costs of care before and after implantation. METHODS: We performed a retrospective database study involving 555 noncancer pain patients that received an IDD system implant within a 3-year service period (1/2006-1/2009). IDD patient costs were temporally aligned to implant month and repriced to a standardized, national pricing schedule over a 6-year episode cycle (3 years preimplant, implant month, and 3 years postimplant). Additionally, we made an actuarial projection of postimplant experience, in the absence of IDD intervention, simulating a conventional pain therapy (CPT) protocol by assuming the same slope in costs prior to implantation at standardized, national price levels. Cost projections were produced over a 30-year time horizon at various reimplantation rates. RESULTS: IDD therapy was less costly than the CPT protocol over our baseline implantation cycle. Costs in the month of IDD implantation, and in the year following, are cumulatively $17,317 more than the CPT protocol; however, IDD financial break-even occurs soon after the second year postimplant. The lifetime analysis indicates that IDD per patient per year savings is $3,111 compared with CPT. CONCLUSION: The authors found that patients receiving an implantable IDD system may experience reduced cumulative future medical costs relative to anticipated costs in the absence of receiving IDD. This finding complements published literature on the cost-effectiveness of IDD.

A cost utilization analysis of intrathecal therapy for refractory cancer pain: identifying factors associated with cost benefit.

OBJECTIVE: Intrathecal therapy (ITT) for cancer pain is characterized by high initial cost followed by low maintenance costs. Non-ITT pain management is associated with steadily increasing cumulative cost that can equal the cost of ITT over time. The intent of this modeling project is to identify factors associated with relatively rapid achievement of cost-benefit with ITT. DESIGN: A retrospective chart review was performed on 36 patients with cancer pain who underwent ITT and survived beyond 4 weeks. METHODS: Data on the cost of conventional opioid therapy prior to ITT and at 4-6 weeks were collected and projected over time. ITT costs included all intrathecal pump implantation and maintenance costs. Pre-ITT opioid regimens were stratified into high-cost conventional (HCC-high-dose, nongeneric, or use of intravenous patient-controlled analgesia, N = 12) and low-cost conventional (low-dose or generic, N = 24) regimens. RESULTS: The median daily cost of opioid medications pre-ITT was $21.26 (25th-75th percentile $10.31-78.85, range 0-$971.97) vs $0 (25th-75th percentile $0-0.70), P = 0.007, post-ITT. In the HCC group, the median daily cost was $172.47 (25th-75th percentile $67.29-406.20). The median daily cost of ITT medications was $16.01 (25th-75th percentile $9.52-23.23).When these data were used to model costs over the long term, including pump implantation costs, cost-benefit for all patients compared with conventional therapy was predicted at 344 months but at 7.4 months in the HCC group. Seven patients (19%) achieved cost equivalence within 6 months and three of these within the first 3 months. CONCLUSIONS: In selected patients on high-cost opioid regimens, ITT may become cost-beneficial within 6 months. Factors associated with earlier attainment of ITT cost-benefit include the use of parenteral therapy, high-dose opioids, and the use of nongeneric opioid products.

Predictors of direct costs of diabetes care in pediatric patients with type 1 diabetes.

OBJECTIVE: This study examines factors that predict elevated direct costs of pediatric patients with type 1 diabetes. METHODS: A cohort of 784 children with type 1 diabetes at least 6 months postdiagnosis and managed by pediatric endocrinologists at Texas Children's Hospital were included in this study. Actual reimbursed costs from January 2004 to December 2005 were obtained. Medication and supply costs were based on estimates from insulin dosage and type of insulin regimen prescribed, respectively. We examined utilization of care, total diabetes-related direct medical costs, and predictors of direct costs and hospitalization. RESULTS: Annually, 7% (58/784) of patients (excluding initial hospitalization at diagnosis) had a diabetes-related hospitalization and median length of stay was days. Mean total diabetes-related direct cost per person-year was $4730 [95% confidence interval (CI), 4516-4944]. Supplies accounted for 38% and medications 33% of costs, respectively. Older age, hemoglobin A(1C) (HbA(1C) ) > 8.5%, use of a multi-injection or pump regimen, living in a non-married household, and female gender were associated with higher annual costs. HbA(1C) > 8.5%, living in a non-married household, and female gender increased the odds of a diabetes-related hospitalization. DISCUSSION: Better metabolic control in patients with type 1 diabetes was associated with lower direct medical costs and lower odds of hospitalization. Marital status of the primary caregiver, irrespective of type of insurance, impacts the patient's healthcare costs and risk of hospitalization. This large single-center US study analyzes cost distribution in children with diabetes and is informative for payers and providers focused on effective management and improving healthcare costs.

Respiratory failure following delayed intrathecal morphine pump refill: a valuable, but costly lesson.

BACKGROUND: Spinal analgesia, mediated by opioid receptors, requires only a fraction of the opioid dose that is needed systemically. By infusing a small amount of opioid into the cerebrospinal fluid in close proximity to the receptor sites in the spinal cord, profound analgesia may be achieved while sparing some of the side effects due to systemic opioids. Intraspinal drug delivery (IDD) has been increasingly used in patients with intractable chronic pain, when these patients have developed untoward side effects with systemic opioid usage. The introduction of intrathecal opioids has been considered one of the most important breakthroughs in pain management in the past three decades. A variety of side effects associated with the long-term usage of IDD have been recognized. Among them, respiratory depression is the most feared. OBJECTIVE: To describe a severe adverse event, i.e., respiratory failure, following delayed intrathecal morphine pump refill. CASE REPORT: A 65-year-old woman with intractable chronic low back pain, due to degenerative disc disease, and was referred to our clinic for an intraspinal drug delivery evaluation, after failing to respond to multidisciplinary pain treatment. Following a psychological evaluation confirming her candidacy, she underwent an outpatient patient-controlled continuous epidural morphine infusion trial. The infusion trial lasted 12 days and was beneficial in controlling her pain. The patient reported more than 90% pain reduction with improved distance for ambulation. She subsequently consented and was scheduled for permanent intrathecal morphine pump implantation. The intrathecal catheter was inserted at right paramedian L3-L4, with catheter tip advanced to L1, confirmed under fluoroscopy. Intrathecal catheter placement was confirmed by positive CSF flow and by myelogram. A non-programmable Codman 3000 constant-flow rate infusion pump was placed in the right mid quandrant between right rib cage and right iliac crest. The intrathecal infusion consisted of preservative free morphine, delivering 1.0 mg /day. Over the following 6 months, the dosage was gradually titrated up to 4 mg/day with satisfactory pain control without significant side effects. However, the patient was not able to return to the clinic for pump refill until 12 days later than the previously scheduled pump-refill date. Her pump was accessed and was noted to be empty. Her intrathecal pump was refilled with preservative free morphine, delivering 4 mg/day (the same daily dose as her previous refill). However, on the night of pump refill, 10 hours after the pump refill, the patient was found to be unresponsive by her family members. 911 was called. Upon arriving, paramedics found her in respiratory failure, with shallow breathing at a rate of 5/min, pulse oxymetry showing oxygen saturation about 55-58%. She was emergently intubated on site and rushed to local hospital ER. The on call physician for our clinic was immediately contacted, and advised the administration of intravenous Naloxone. Her respiratory effort improved dramatically after receiving a total of 0.6 mg IV Naloxone IV over 25 minutes. Her intrathecal pump was immediately accessed by clinic on call physician and the remainder of the medication in the catheter space was aspirated. The pump infusate was immediately diluted with preservative free normal saline, to deliver preservative free morphine at 1mg/day. She was transferred to the intensive care unit and extubated the next morning. She recovered fully without any sequelae. CONCLUSION: Loss of opioid tolerance due to delayed pump refill may subject patients to the development of severe respiratory depression. Meticulous approach should be employed when refilling pumps in these patients when their pumps are completely empty. To our knowledge, this is the first reported case of this type.

Practice choices and challenges in the current intrathecal therapy environment: an online survey.

OBJECTIVE: The objective of this study was to evaluate current practice characteristics, treatment choices, clinical experiences, and economic concerns associated with intrathecal therapy. DESIGN: Health care professionals in the United States, who were known to actively use intrathecal therapy in their practices, were recruited to participate in an online survey; contact information was obtained via Internet searches, university Websites, association memberships, industry databases, and personal contacts. Survey responses were summarized descriptively. RESULTS: Of the 329 practitioners who were contacted, 87 participated in the survey. Most participants specialized in anesthesiology (77.0%), worked in a private practice or private hospital (74.7%), and had been practicing pain management for more than 10 years (64.4%). Morphine was the most frequently used opioid for the initiation of intrathecal therapy (80.7% of practitioners), and 81.9% had used ziconotide in their practice. Most practitioners (63.9%) had treated at least one patient who developed a granuloma, and 66.0% of those practitioners had a patient experience permanent or temporary neurological injury due to a granuloma. Fewer than half of practitioners were satisfied with reimbursement from private insurance companies (25.3%) or workers compensation (34.9%), and 90.5% believed reimbursement rates for filling, refilling, and programming patient pumps are not adequate to cover practice costs. The majority of practitioners (56.6%) use fewer pumps in their practices because of reimbursement issues. CONCLUSIONS: Intrathecal pain management practices continue to evolve as the options for treatment increase, and the body of applicable scientific literature grows; however, economic considerations can influence clinical decisions and may interfere with treatment choice and patient access to therapy.

Multiple daily injections in young patients using the ezy-BICC bolus insulin calculation card, compared to mixed insulin and CSII.

OBJECTIVE: To describe the easy bolus insulin calculation card (ezy-BICC) approach to multiple daily injections and to compare in an observational study, the haemoglobin A1c (HbA1c) achieved while using ezy-BICC, mixed insulin injections and continuous subcutaneous insulin infusion (CSII). METHODS: HbA1c results from 7121 clinic visits by 573 patients aged 1-20 yr using the three methods between June 2000 and July 2008 were reviewed. RESULTS: For mixed insulin median, mean and SD HbA1c were 8.3%, 8.3%, 1.33, for ezy-BICC, 7.6%, 7.7%, 1.40, and for CSII, 7.6%, 7.8%, 1.31. HbA1c increases with age significantly more in those using CSII (p < 0.001). By regression, compared with mixed insulin HbA1c is 0.7% lower using ezy-BICC (p < 0.018) and 1.5% lower using CSII (p < 0.001). For patients using CSII compared with <6 yr, those 6-12 yr have HbA1c 0.7% higher (p < 0.001), 12-15 yr 1.0% higher (p < 0.001) and 15-20 yr 1.2% higher (p < 0.001). For subjects >12 yr, HbA1c is lower while using ezy-BICC than CSII. HbA1c increases 0.2% per yr following diagnosis for 2.8 yr. In those who change from mixed insulin to ezy-BICC after this time, the mean HbA1c is 0.5% lower by 9 months, 0.7% lower at 21 months and 0.6% lower at 24 months (p < 0.05). CONCLUSIONS: The ezy-BICC system is inexpensive and convenient and allows patients to vary meal size. Subjects achieve lower HbA1c while using CSII and ezy-BICC MDI than with mixed insulin. Very young subjects achieve excellent HbA1c using CSII, but for 12 to 20 yr-old patients, ezy-BICC results in lower HbA1c than CSII for a lower cost.

A home-made low-cost hydraulic swivel and catheter assembly for blood pressure recording and drug infusion in freely moving mice.

We constructed a chassis that tightly fixes catheters for cannulation to the muscle. It can buffer pulling forces to avoid a mechanical tearing of the skin of mice as a result of movement. A simple hydraulic swivel was also made for blood pressure recording and drug infusion in freely moving mice.

[Management of increase in spasticity in patients with intrathecal baclofen pumps]. / Conduite à tenir devant une recrudescence de spasticité chez un patient porteur d'une pompe à baclofène.

INTRODUCTION: The incidence of complications after baclofen pump implantation is relatively high. Diagnosis of these complications can be difficult. A diagnostic tree would be a useful tool in cases of suspected malfunctioning of the intrathecal bacolfen infusion system and would standardise the diagnostic procedure. METHOD: From results in the literature and the experience of our department, we designed a diagnostic tree to aid in finding the cause of a recrudescence of spasticity in patients with implanted baclofen pumps. RESULTS: The potential causes of recrudescence of spasticity are described and a diagnostic pathway is proposed. DISCUSSION: The aim of a standardised hierarchical method of diagnosis of the cause of increased spasticity in patients with intrathecal baclofen pumps is to gain time in the diagnosis and treatment. Such diagnosis should improve patient care by permitting rapid restoration of an adequate level of baclofen infusion as well as decreasing the length of hospital stay and, as a consequence, the cost relating to malfunctioning pumps.