Related manufacturer report numbers: 3003306248-2022-12529, 3003306248-2022-14506, 3003306248-2022-14507.It was reported that while the patient was being moved from one bed to another on full centrimag support with no prior equipment issues or malfunctions, the console power cable was unplugged and the entire system shut down.The power cable had been plugged into the patient's bed and not into the ac wall power.The team began the procedure to switch to back up equipment.They stated the backup equipment would not turn on initially either.It was also plugged into the patient's bed and not to ac power.Eventually, they were able to place the patient on backup equipment.During this time, the patient required bag ventilation.The patient's blood oxygen saturation was reported to be approximately 70-79%.No inotropes or other interventions were initiated.The team stated there was no alarm.The system "just shut off completely".
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Manufacturer's investigation conclusion the centrimag motor (serial number (b)(6)) was evaluated following the reported event of the primary console and motor shutting down after the system was unplugged from ac power.The centrimag motor was not returned for analysis; however, the reported event could not be correlated to an issue with the motor due to the motor being dependent on the console.It was reported that while the patient was being moved from one bed to another on full centrimag support with no prior equipment issues or malfunctions, the customer accidentally unplugged the power cable of the console after which the entire system shut down.If the console is shut down or turns off, the motor will turn off as well.Please see the centrimag 2nd generation console investigation (addressed in manufacturer report number 3003306248-2022-12529) for more information regarding the console.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.The products are assumed to not be returning to abbott.If the products return, the investigations will reopen.The root cause of the reported event could not be correlated to an issue with the motor.Review of the device history record for the centrimag motor, serial number (b)(6), showed the motor was manufactured in accordance with manufacturing and quality assurance specifications.The 2nd generation centrimag system operating manual, rev.M, section 4 "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." no further information was provided.The manufacturer is closing the file on this event.
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