Model Number 8637-40 |
Device Problem
Volume Accuracy Problem (1675)
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Patient Problems
Fall (1848); Overdose (1988); Blurred Vision (2137); Dizziness (2194); Reaction (2414); No Known Impact Or Consequence To Patient (2692)
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Event Date 12/01/2016 |
Event Type
Injury
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Event Description
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Information was received from a company representative regarding a patient currently receiving dilaudid and bupivacaine dose and co ncentration not reported via an implantable pump.The pump had previously been delivering fentanyl, bupivacaine and dilaudid dose and concentration not reported.The indications for use were non-malignant pain and degenerative disc disease.The patient reported a volume discrepancy.Per the patient the last 3 times they were refilled there was a suspicion there was more medication then expected at refill time.The patient was scheduled for a catheter dye study on (b)(6) 2017.The patient stated that they were refilled about every 6 weeks.The patient was wondering if a company representative could be paged to be at their next refill date (b)(6) 2017 and also the patient¿s upcoming catheter dye study.There were no patient symptoms reported.
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received by a consumer on 27-mar-2017.It was reported that the volume discrepancies varied.There was no noticeable cause in the patient's volume changes other than a physical reaction.A dye study was done on (b)(6) 2017.There was no noticeable evidence of abnormal catheter function.It was noted that the patient had an apparent change in physiological reaction with no obvious mechanical cause.A new pain pump was implanted, which replaced the older unit.Replacing the unit was anticipated to resolve the issue.No further patient complications were reported.
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from a healthcare provider (hcp) and a device manufacturer representative (rep).The patient was consistently having 6-8 ml of reservoir discrepancies at refills for the past year.No environmental, external, or patient factors were noted to have led or contributed to the issue.The pump was replaced on (b)(6) 2017.The issue was resolved and the patient was noted to be "alive-no injury".The patient was receiving 20 mg/ml dilaudid at 12.5 mg/day and 20 mg/ml bupivacaine at 12.5 mg/day.No further complications were reported or anticipated.
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Manufacturer Narrative
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Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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The pump was returned for analysis.
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Manufacturer Narrative
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The pump was returned for analysis.The pump logs indicated that the pump had been used to deliver dilaudid (20 mg/ml at 12.538 mg/day) and bupivacaine (20 mg/ml at 12.538 mg/day).Pump analysis found gear train anomalies of a stall due to shaft bearing and corrosion, wear or lubrication.(b)(4).If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from a consumer indicated there was a high concern in the implant device¿s function.It was noted the previous reported discrepancies consisted of unreliable over doses resulting in dizziness, blurred vision, and numerous falls.There was no change in the malfunctioning device ¿i.E.Same physiological reactions, total unreliability.¿ it was noted the patient¿s volume discrepancies had been resolved.Steps taken to resolve the volume discrepancies were intrathecal implant pump replacement, post two month wait.No further complications were reported/anticipated or expected.
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Search Alerts/Recalls
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