MAUDE Adverse Event Report: HEARTWARE, INC HEARTWARE VENTRICULAR ASSIST SYSTEM; CIRCULATORY ASSIST SYSTEM

Catalog Number 1103

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2015

Event Type  malfunction  

Manufacturer Narrative

Patient's height: (b)(6).Patient's bsa: (b)(6).This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings.The pump/driveline remains implanted.The instructions for use and patient manual warn: do not drop the controller or other equipment.Dropping the controller could cause sudden stoppage of the pump.Dropped equipment should be reported and inspected.Additionally it outlines that the driveline cover should completely cover the controller's silver driveline connector to protect it and keep it clean.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.Device remains implanted.

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM
• Type of Device: CIRCULATORY ASSIST SYSTEM
• Manufacturer (Section D): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 3105
• Manufacturer (Section G): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 3105
• Manufacturer Contact: tatyana chorny ; 14400 nw 60th avenue; miami lakes, FL 33014-3105 ; 3053641476
• MDR Report Key: 5019269
• MDR Text Key: 23682749
• Report Number: 3007042319-2015-01957
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 64 YR
• Patient Weight: 123