It was reported that, approximately six weeks after the ventricular assist device (vad) implant procedure, the vad exhibited suction alarms which were attributed to the patient's dehydration.The patient was advised to increase their oral fluid intake and their diuretic dosage may be adjusted if the suction events continue.The vad remains in use.No further patient complications have been reported as a result of this event.
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This regulatory report is being submitted as part of a retrospective review and remediation per (b)(4) due to an fda audit observation.This information was received from the mechanical circulatory support product surveillance registry study.Product event summary: the ventricular assist device (vad) (b)(4) was not returned for evaluation.The reported suction event was not confirmed via review of the controller log files since log files covering the reported event date were not available for analysis.Information provided by the site indicated that, approximately six weeks after the ventricular assist device (vad) implant procedure, the vad exhibited suction alarms which were attributed to the patient's dehydration.The patient was advised to increase their oral fluid intake and their diuretic dosage may be adjusted if the suction events continue.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.There was no evidence that the patient had a history of similar adverse events.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.If information is provided in the future, a supplemental report will be issued.
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