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Model Number 8637-20 |
Device Problems
Excess Flow or Over-Infusion (1311); Increase in Pressure (1491); Material Deformation (2976)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/24/2019 |
Event Type
malfunction
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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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Information was received from a healthcare provider via a manufacturer's representative regarding a patient receiving compounded baclofen (50 mcg/ml at 35 mcg/day), morphine (15 mg/ml at 10 mg/day), fentanyl (8500 mcg/ml at 6049 mcg/day), bupivacaine (30 mg/ml at 21 mg/day), and dilaudid (15 mg/ml at 10 mg/day) via an implanted pump.The indication for use was non-malignant pain.It was reported there was a volume discrepancy at replacement and the pump was concaved posteriorly on (b)(6) 2019.When the pump was heated with hot water upon cleaning for return, the pump popped back out.Repeated several times before sending pump back.It was noted the patient had been scuba diving up to 100 feet.The patient heard the pump collapse/get pushed when diving and feels/hears it pop back out.This current pump¿s drug was aspirated <(>&<)> transferred to new pump on back table.The expected volume was 19.6 ml, actual volume aspirated 15 ml.Not sure scrub tech aspirated fully.There were no diagnostics or troubleshooting performed.The pump was replaced for end of service and the issue resolved.The pump was to be sent back to the manufacture.The patient's weight was (b)(6).
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Manufacturer Narrative
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The pump was returned, and analysis found a stall due to shaft-bearing and corrosion and-or wear and-or lubrication.The pump exterior was concave.The catheter was returned, and analysis found coring-tears-cuts in seal of the sc connector.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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