Catalog Number 201-90411 |
Device Problems
Failure to Charge (1085); Low Battery (2584); Power Problem (3010)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/27/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Device unique identifier (udi) ¿ device was manufactured prior to the udi labeling implementation.Approximate age of device - the centrimag primary console is not a single use device.The approximate age of the device from the date of manufacture is 4 years and 1 month.No further information was provided.A supplemental report will be submitted when the manufacturer's' investigation is completed.
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Event Description
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The patient was implanted with an extracorporeal circulatory support device.It was reported that the patient was being transported from the operating room to the intensive care unit, and that the device had been set at the maximum speed to achieve the highest possible flows.It was reported that the battery charge indicator changed from 6 hours to 1.75 hours when battery support was initiated for transport.The battery was quick to discharge thereafter.The perfusionist was able to transport the patient to the recovery room by plugging the console into outlets for a short period of time en route.It was reported that the device flows remained stable during the transport.Upon arrival in the recovery room, the console was plugged into ac power; however, the battery indicator light did not immediately indicate the unit was charging.As a precaution the patient was placed on the backup console.No patient harm was reported.No additional information was provided.
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Manufacturer Narrative
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The console was not returned to the manufacturer for evaluation.A direct correlation between the device and the reported reduced battery support time and inability for the battery to recharge could not be conclusively determined.Based on the information received at the time of the event, the patient was placed on the backup console with no issue.Several unsuccessful attempts were made to obtain additional information from the customer.A review of the device history records revealed the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.
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Search Alerts/Recalls
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