Model Number 8637-20 |
Device Problems
Premature Elective Replacement Indicator (1483); Inappropriate or Unexpected Reset (2959)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/15/2020 |
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 manufacturer's representative regarding a patient who was receiving an unknown drug via an implantable infusion pump.It was reported that the patient was going to the bathroom and fell over.The patient attempted to give themselves a bolus and the patient programmer showed a 8310 code.It was reported that the pump had reset and there was no reservoir volume seen on the pump status.No symptoms were reported.No further complications were reported.
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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 manufacturer's representative (rep).It was reported that the pump would be replaced on (b)(6) 2020.No further complications were reported.
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Manufacturer Narrative
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Device codes have been updated to include (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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On 2020-feb-19, additional information was received from the manufacturer representative (rep).It reports the cause of the pump re set was not determined.The rep stated, "patient's pump is delivering minimum rate at the moment and no way to enter reservoir volume anywhere".It was noted the pump went from eri (b)(6) 2022 to eri (b)(6) 2020.The patient has been put in for a replacement and depending on how his health is, he may or may not get a replacement.The patient "may get a explant according to physician".
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Search Alerts/Recalls
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