This regulatory report is being submitted as part of a retrospective review and remediation per (b)(4) due to an fda audit observation.Product event summary: the ventricular assist device (vad) (b)(4) was not returned for evaluation.The reported suction event was confirmed via review of the controller log files which revealed 42 suction alarms have been logged since (b)(6) 2020.Information provided by the site indicated that the ventricular assist device (vad) exhibited suction alarms.It was noted that the patient was very sensitive and dependent on volume state and had no symptoms during the suction alarms.Based on the available information, the device may have caused or contributed to the reported event.Based on risk documentation, multiple factors may have contributed to the suction event including but not limited to thrombus at the inflow cannula/outflow graft, constriction at the outflow graft, poor vad filling, and/or inappropriate pump rotational speed.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the therapeutic use of anticoagulant and antiplatelet medications and the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to this event.Investigation of this event is completed and the file will be closed.If new information is received, the file will be re-opened and a supplemental will be submitted.
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