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Model Number 201-30100 |
Device Problems
Pumping Stopped (1503); Power Problem (3010)
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Patient Problems
Cardiac Arrest (1762); Death (1802)
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Event Date 01/15/2018 |
Event Type
Death
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Manufacturer Narrative
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The initial submission of this event was reported by the manufacturer under mfr.Report # 2916596-2018-00844.This report is being submitted as additional information.Approximate age of device- 10 years, 6 months.Manufacturer's investigation conclusion: the reported event could not be confirmed nor reproduced during testing of the returned centrimag primary console.The returned console was evaluated and tested by the service depot.The reported event could not be duplicated during their evaluation.The unit's internal battery was allowed to charge for 12 hours.The unit was then turned on and powered up normally without any issues.The console supported a test motor and pump without any issues.A battery minimum run-time test was performed and the unit passed while running a mock circulatory loop at 5000rpm and 9.01lpm.The unit ran for 48 minutes until a low battery status and ran for a total of 68 minutes until the "battery below minimum" warning activated.No battery malfunction or any other issues were observed during testing.Visual inspection of the unit did not reveal any issues.The unit required battery maintenance, which was then performed without any issues.The returned console was found to function as intended.As a result, the root cause of the reported event could not be conclusively determined.Reports of similar events will continue to be tracked and monitored.Centrimag motor instructions for use instructs to always have a back-up centrimag motor available.Centrimag blood pump instructions for use states "always have a spare centrimag blood pump, back-up console and equipment available for change out." centrimag primary console operating manual warns "one back-up console and motor are required in the immediate vicinity of each patient whenever the centrimag blood pump is used.The back-up console must be connected to the back-up motor, have a battery charge sufficient for at least one hour of operation, be connected to ac power (except during transport) and be immediately available should the primary console or primary motor experience a malfunction.".No further information was provided.The manufacturer is closing the file on this event.
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Event Description
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The patient was being supported with an extracorporeal circulatory support pump.It was reported that the centrimag (cmag) primary console had a battery failure that caused a momentary pump stop.The event occurred when the patient was transported for a ct.After 15-20 minutes of being unplugged from ac power, rpms suddenly dropped to 0 and the primary console alarmed ¿battery malfunction¿.There were no other alarms prior to the event.The primary console was plugged back into ac power; however, rpms remained at 0 with message of ¿battery malfunction¿.The pump and motor were then switched to the backup console and the pump resumed.At the time of the pump stop, the patient¿s condition worsened and the patient arrested, but was resuscitated.The patient was stabilized after the pump stoppage and remained on support for several weeks.Per the patient¿s wishes, care was withdrawn on an unspecified date and the patient expired.No further information was provided.
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Search Alerts/Recalls
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