Voluntary medwatch number mw5113026 was received 04-nov-2022.Manufacturer's investigation conclusion: the reported event of a centrimag not being able to function properly was unable to be confirmed.The centrimag 1st generation primary console was not returned for analysis and no log files were submitted for review.Multiple good faith efforts were sent asking for the serial number of the centrimag console, if there was any patient impact related to the console exchange due to centrimag failure, if there were any events leading up to the reported failure, and if any products would be returned for evaluation.To date, no response has been received.A root cause for the reported event was unable to be conclusively determined through this analysis.The device history records were unable to be reviewed for the centrimag 1st generation primary console due to no serial number being provided.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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