Model Number 102954 |
Device Problem
Pumping Stopped (1503)
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Patient Problem
Death (1802)
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Event Date 11/05/2019 |
Event Type
Injury
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Manufacturer Narrative
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Patient age was not provided.Serial number was not provided.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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It was reported that the centrimag motor stopped.According to additional information provided, the patient expired on (b)(6) 2019 due to another cause.The device will be sent for repair.No further detail was provided.
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Event Description
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Patient was on lvad cmag 1st generation console.Transported to ct scan and discovered brain ischemia.Transported back to intensive care unit (icu) flow on 1st gen console; hemodynamics remained stable.Customer reported he felt motor and felt it vibrating as if it was flowing, but the motor felt a little warmer.They switched to another 1st gen console and that didn¿t resolve the problem.They switched to a second motor and that resolved the problem.Later they placed the motor that had the problem with on a demo loop and the problem reoccurred.The next day, they spoke with the family about the brain ischemia and discontinued support.Patient expired (b)(6) 2019 but not due to centimag motor failure.Educated the perfusionist on to switch console and motor, and figured the problem out later.Not to plug the system into a power strip, plug directly into outlet.Not to share outlet with other large medical devices.No further information was provided.
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Event Description
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Additional information was received on (b)(6) 2020.The console failed during a routine pm.It would not read the flow rate accurately.It was boxed and ready to be returned for evaluation regarding the flow rate issue.
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Manufacturer Narrative
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Section b5, d4: additional information.
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Event Description
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Patient death reported under mfr # 2916596-2019-05309.
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Manufacturer Narrative
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Manufacturer's investigation conclusion: the centrimag 1st generation primary console (serial #: (b)(6) ) was evaluated for the reported event of the centrimag motor stopping.The console was not returned for analysis; however, the associated centrimag motor (serial #: (b)(6) ) was returned for analysis and the reported event was confirmed and motor cable damage was found.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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Search Alerts/Recalls
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