Product event summary: the pump and controller were returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the devices in relation to the reported event.Failure analysis of the returned pump revealed that the device passed visual examination, functional testing, and dimensional verification.Internal pathological report revealed no evidence of thrombus within the device.Failure analysis of the returned controller revealed that the device passed functional testing.A visual inspection under 10x magnification revealed a hairline crack around power port two (2).An internal inspection did not reveal evidence of fluid ingress.The observed hairline crack is not related to the reported event.The root cause of the hairline crack was determined to be due to chemical additives applied to the power port gaskets during the manufacturing process.The chemical additives contributed to environmental stress cracking.The reported low flow event was confirmed through log file analysis, which revealed 100 low flow alarms logged since december 19, 2017.Log file analysis also revealed a controller power up and motor start event on december 21, 2017 at 21:50:54.The controller was without power for 13 minutes and 22 seconds.As a result, the reported power l oss event was confirmed.Based on the available information, the most likely root cause of the power loss event can be attributed to the reported disconnection of both power sources from the controller.Based on risk documentation and the available information, possible causes of the low flow event may be attributed to multiple factors including but not limited to constriction at the outflow graft, poor vad filling, and/or patient factors.Other devices involved in this event: heartware ventricular assist system ¿ controller 2.0 model 1420 serial number: (b)(4), expiration date: 2018-04-30 udi (b)(4).Device eval 2018-01-30 mfg date: 2017-04-30 (b)(4).If information is provided in the future, a supplemental report will be issued.
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