Model Number 8637-40 |
Device Problem
Premature Elective Replacement Indicator (1483)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/05/2019 |
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 the healthcare provider (hcp) via a device manufacturer representative regarding a patient receiving hydromorphone (6 mg/ml 2 mg/day) via an implantable infusion pump.The indication for use was spinal pain.It was reported that during the last refill appointment the elective replacement indicator (eri) was noted to occur in (b)(6) 2021 but the pump started to alarm and upon interrogation it was read that it would reach eri on (b)(6) 2019 at 10:48 pm.No symptoms were reported.No further complications have been reported as a result of this event.
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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 the device manufacturer representative indicated that the pump would be replaced on (b)(6) 2019.No further complications have been 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 the healthcare provider indicated that the cause of the early elective replacement indicator was unknown.It was noted that the pump would be replaced in (b)(6) 2019.No further complications have been reported.
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Manufacturer Narrative
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The pump was returned and analysis found electrochemical migration across the electrical feed-through insulator.
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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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Search Alerts/Recalls
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