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Model Number 8637-40 |
Device Problems
Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/09/2018 |
Event Type
Injury
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Manufacturer Narrative
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Continuation of medical devices: product id 8780, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2018, product type catheter.Information references the main component of the system.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 21-sep-2014, udi#: (b)(4).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 company representative regarding a patient receiving morphine (unknown form) 50mg/ml at 22.49mg/day, fentanyl 600mcg/ml at 269.90 mcg/day, bupivacaine 7.5mg/ml at 3.37 mg/day, and ketamine 4.0mg/ml at 1.799 mg/day flex dose via an implantable pump.The indications for use were non-malignant pain and failed back syndrome-other.On (b)(6) 2018 it was reported that per the healthcare provider at the refill on (b)(6) 2018, 27ml¿s were removed from the reservoir and 5.7ml¿s were expected.On (b)(6) 2018 at the refill 20ml¿s was removed and 4.8ml¿s were expected.At the time of the replacement intra-op 10ml¿s was removed and 2ml¿s were expected.The patient did not mention any change in pain level.It was unknown it there were any environmental, external or patient factors that may have led or contributed to the issue.The catheter was replaced and intra-op it was found that there was a black unknown substance at the tip of the catheter.The pump was also replaced at the time of the catheter replacement due to eri (elective replacement indicator).Following replacement post-op the pump was used to deliver infumorph 25 mg/ml at 10mg/day.The issue was resolved at the time of the event and it was noted that the healthcare provider would not have any further information regarding the event.The patient status was noted as alive, no injury and no further complications were reported.
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Search Alerts/Recalls
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