Manufacturer investigation conclusion: the reported event of a s3 alarm was confirmed via the log file.The centrimag motor was returned to mcs (b)(4) for analysis and was investigated by (b)(4).The reported event of a s3 alarm was able to be confirmed via the log file; however, it was not able to be reproduced.A log file was downloaded from the associated and returned console.A review of the downloaded log file showed an ifd-shutdown (display dark) sub fault active on (b)(6) 2019 at 05:01.The sub fault triggered a ¿system alert: s3¿ and a ¿set pump speed not reached: m5¿ alarms.The speed dropped from 4300 rpm (flow of 3.8 lpm) to 3420 rpm with 0 lpm of flow displayed.A further investigation on the returned devices was performed by the r&d department of mcs (b)(4).Although the reported event could not be reproduced, reports of similar events have been documented and corrective action had been initiated to investigate the issue.The investigation has determined that this event was caused by a motor related issue.The motor was forwarded to mcs (b)(4) and was evaluated and tested.The motor was connected to a test console, pump, and mock loop.The motor was able to support the pump at the set speed without any issues.The reported event was not reproduced during testing.The device returned for analysis.The complaint investigation determined the reported event was the result of a software design related issue.After review of this event and similar incidents, abbott has decided to initiate a voluntary field action for centrimag.Abbott performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis no further information was provided.The manufacturer is closing the file on this event.
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