THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
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Model Number 102956 |
Device Problem
Device Difficult to Setup or Prepare (1487)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/04/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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 customer was unable to properly insert the centrimag disposable pump head into the drive motor.They swapped it out for another motor and was then able to insert the pump head properly.
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Manufacturer Narrative
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Manufacturer's investigation conclusion: the reported event of the pump not inserting into the motor was not confirmed.The centrimag motor was returned for analysis to the service depot and the reported event was unable to be reproduced.A test pump was inserted into the motor several times and was able to operate as intended with no alarms.The motor was functionally tested and performed as intended.The root cause for the reported event was unable to be conclusively determined through this analysis.The device history records were reviewed for the centrimag motor and the motor was found to pass all manufacturing and quality assurance specifications.The 2nd generation centrimag system operating manual section 4 entitled "warnings & precautions" warns "one additional 2nd generation centrimag primary console, motor and flow probe are required as backup system in the immediate vicinity of each patient whenever the centrimag or pedivas blood pump is used.The backup console must be connected to the backup motor and to the backup flow probe, 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 main console, motor or flow probe experience a malfunction." the 2nd generation centrimag system operating manual section 10 entitled "emergency and troubleshooting" states that "the recommended practice whenever there is a 2nd generation centrimag primary console or motor malfunction is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console and place the blood pump in the backup motor and console to continue patient support.Do not exchange individual motors or individual consoles during patient support." no further information was provided.The manufacturer is closing the file on this event.
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