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 08/08/2019 |
Event Type
Injury
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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 (hcp) via a company representative regarding a patient who was receiving baclofen with concentration 2000.0 mcg/ml at a dose rate of 1050.6 mcg/day via an implantable pump for head/brain injury and intractable spasticity.It was reported that a pump alarm occurred due to an unexpected elective replacement indicator (eri).It was noted that at the last refill on (b)(6) 2019 everything went fine and on the report, it stated the patient had 24 months until eri would occur.However, today ((b)(6) 2019) when the patient came in for a refill, the report was indicating that eri occurred.As per the provided report, eri occurred on (b)(6) 2019.At the time of the report it was reviewed to retrieve the pump logs to see if there were any other anomalies that might have occurred.Upon review of the provided logs, it was reviewed that it was just eri that occurred with no other anomalies.It was being considered that it appeared like a premature eri case at this point and that they really wouldn¿t know the reason why until the pump gets sent back to the manufacturer for analysis.Scheduling a replacement soon as they won¿t know if eos would occur on the date provided or not was being considered.It was confirmed that there was no programming error.The patient was described as living in a nursing facility so they would have care if anything were to happen with the pump.No patient symptoms were reported.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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The type of report was changed from previously being a reportable malfunction to now a reportable serious injury.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 via a company representative.The pump was still showing premature elective replacement indicator (eri).The patient required increased monitoring at the facility, travel to and from the medical campus, and would require surgical intervention.Pump replacement was scheduled to occur (b)(6)2019.The pump was planned to be returned to the manufacturer.The patient¿s weight at the time of the event was unavailable.
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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.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 to the manufacturer for analysis.
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Manufacturer Narrative
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Analysis of the pump identified electrochemical migration across the electrical feed-through insulator.The previously reported evaluation conclusion, result, and method codes no longer apply.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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