Manufacturer's investigation conclusion: the reported event of an s3: system fault alarm was confirmed.A log file was extracted from the centrimag console (serial number (b)(6), returned and functionally evaluated under a separate event).An s3 alarm was observed on (b)(6) 2022 at 16:33 correlating to a fan-related sub-fault.The system was not observed to have been in patient use at this time.No other notable events within the timeframe of this event (sep2022) were observed.The centrimag console was not returned for analysis under this event.The root cause of the reported event was unable to be conclusively determined through this analysis.Review of the device history record for centrimag 2nd gen.Primary console, serial number (b)(6) showed the device was manufactured in accordance with manufacturing and qa specifications.The 2nd generation centrimag system operating manual (rev.M, section 4 "warnings and 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 (rev.M) section 11.1-"appendix i ¿ console alarms and alerts" contains a list of console alarms and alerts, including s3 alarms, 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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