Model Number 8637-20 |
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 05/14/2017 |
Event Type
Injury
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.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 health care provider (hcp) via a manufacturer representative regarding a patient with an implantable drug infusion pump indicated for intractable spasticity and cerebral palsy.The pump contained an unknown drug at an unknown concentration and dose.It was reported the hcp was called into clinic to see the patient on (b)(6) 2017 who reported her pump was alarming.The patient was completely asymptomatic, but her pump had been alarming about every 45 minutes for the last few days.On interrogation, it showed that the early replacement indicator (eri) alarm had started on (b)(6) 2017, and the pump needed to be replaced by (b)(6) 2017.The patient¿s actual eri wasn¿t for 20 months.The hcp stated they knew they were recently warned about that by the manufacturer, but they just needed to know how to proceed with replacement.The eri alarm was unexpected.No further patient complications were reported.
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.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 received from the representative on (b)(6) 2017 reported there was no resolution at that time.The recommendation was to have the pump replaced sooner versus later, so they were trying to coordinate that between surgery and the patient.The surgery date was unknown at that time.The status of the pump was that it was currently implanted.The plan would be to return it at the time of the replacement.The patient¿s weight was unknown.
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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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