Vad coordinator (b)(6) called clinical specialist to report she received a call this morning from a nurse at local rehab facility stating that the patient's driveline fell out of the controller.The vad coordinator went to the rehab to assess the situation.The patient reported that he got up to use the bathroom and the patient pack containing the controller fell on the ground.The patient reported that at that time, the driveline became disconnected from the controller and the patient and staff had difficulty reconnecting the driveline to the controller.It was further reported that the white driveline cover was off when the connector disconnected.The driveline was reconnected and there were no alarms following the event.The coordinator visually inspected the driveline connector and did not notice any damage to the connector.She tugged on the driveline and the driveline connector remained engaged and the alarms were not reproducible.The pump-off time was greater than nine minutes with report that the patient was without symptoms during the event.Log files were for review by the manufacturer.Multiple vad disconnects, and electrical faults were noted over a time period of about 10 minutes.The patient was transferred back to the implanting center.The patient's inr on (b)(6) was 2.5 and was receiving coumadin the evening of (b)(6) 2015.An echocardiogram was to be done on admission.On (b)(6) 2015, the manufacturer's clinical engineering to arrived at the hospital to assess the driveline with the service evaluation reporting the following: the connector locking mechanism was inspected and tested through pulling from the connector nut.The driveline was disconnected for less than 30 seconds in order to inspect the internal pins and connector body.Visual inspection showed no defects or damage on the connector.No further action was recommended.
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The pump was not returned as it remains implanted.Review of the manufacturing documentation confirmed that the associated pump ((b)(4)) met all requirements for release.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.The reported event was confirmed via review of the controller log files, which revealed electrical fault, high watt, and vad disconnect alarms on the reported event date.Visual examination of the driveline connector did not reveal any damage.There is no evidence to suggest that a device malfunction caused or contributed to the reported event.There are no apparent contributing clinical factors to the reported event.The most likely root cause of the reported alarms is the patient dropping the controller, causing the driveline to partially/completely disconnect from the controller.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.
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