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.The reported "harsh" sound could not be confirmed due to insufficient evidence.Of note, it was reported that intravenous anticoagulation was administered.There is no evidence to suggest that a device malfunction caused or contributed to the reported event.Based on the historical review of similar events, the most likely root cause of the reported event may be attributed to thrombus formation/ingestion.Based on historical review of similar events, the reported harsh noise may be attributed to factors such as thrombus ingested within 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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It was reported that the patient was hospitalized and ¿harsh¿ ventricular assist device (vad) sounds were noticed.The patient also experienced elevated lactate dehydrogenase (ldh), hemolysis, and hematuria.Logfiles revealed suction event and power spike which may have precipitated thrombus.Hemodynamics started to deteriorate.The patient was treated with intravenous (iv) anticoagulation and antiplatelet therapy.The vad was exchanged.No further patient complications have been reported as a result of 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.
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