Product event summary: a pump with unknown serial number was not returned for evaluation.The reported event was not confirmed via review of the controller log files since log files covering the reported event date were not available for analysis.There is no evidence to suggest that a device malfunction caused or contributed to the reported event.Based on the available information and risk documentation, the most likely root cause of the reported event may be attributed to improper positioning of the pump.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.This event was reported in the q4 2020 intermacs data registry that tracks clinical outcomes of patients on ventricular assist device (vad) support.The data registry does not contain device identifying information or event date and therefore cannot be correlated to any previously received report of the event.Based on the provided data, device analysis will not be possible and no further information will likely be made available concerning the 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.If information is provided in the future, a supplemental report will be issued.
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