THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
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Model Number 102956 |
Device Problem
Disconnection (1171)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/27/2019 |
Event Type
Injury
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Manufacturer Narrative
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The event is also reported in cmag console under mfr #2916596-2019-05625.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 motor was reportedly not being recognized with the console and showed motor disconnect alarm.No patient was involved with this event.According to additional information provided, the motor was swapped out but the alarm did not resolve.No further information was provided.
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Manufacturer Narrative
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Section h3: although the customer stated that the product would be returned for evaluation, no product has been received to date.Multiple attempts were made to obtain product return information but this information was not provided.Additional information.Manufacturer's investigation conclusion: the reported event of a m2 alarm was not confirmed.The centrimag motor (serial #: (b)(6) was not returned for analysis.No log files or photos were submitted for review.The root cause for the reported event was not conclusively determined through this analysis.\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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