Related manufacturer's report number: 2916596-2020-06300 for centrimag 2nd generation primary console (b)(4).Related manufacturer's report number: 2916596-2020-06302 for centrimag motor, us (b)(4).Related manufacturer's report number: 2916596-2020-06303 for centrimag motor, us (b)(4).It was reported that the patient was on bivad centrimag pumps.The centrimag was unplugged from the wall with full battery status and the pump shut off.Both consoles and motors were exchanged to back-up devices.
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Section a: patient information was requested but not provided.Manufacturer's investigation conclusion: the reported event of the pump stopping was not confirmed.The centrimag 2nd generation primary console (serial #: (b)(6)) was returned for analysis and a log file was downloaded for review.A review of the downloaded log file showed events spanning approximately 11 days ((b)(6) 2019, (b)(6) 2020, (b)(6) 2021 per time stamp).Events occurring on (b)(6) 2021 took place during lab testing at abbott.There were no atypical pump stop events active in the log file.The centrimag 2nd generation primary console was functionally tested with both of the returned motors and a test loop and operated as intended.The console was also teste with a test motor and test loop and operated as intended.The reported event was unable to be reproduced during this investigation.The console passed all functional testing before being returned to the customer.Multiple good faith efforts were sent to retrieve additional information including if there were any adverse events and the patient status; however, no response was received.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 2nd generation primary console (serial #: (b)(6)) and the console 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." the 2nd generation centrimag system operating manual section 12.1 entitled "appendix i ¿ primary console alarms and alerts" contains a list of console alarms and alerts, as well as appropriate operator response to these events.No further information was provided.The manufacturer is closing the file on this event.
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