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

Catalog Number 1401DE

Device Problems Device Alarm System (1012); Device Handling Problem (3265)

Patient Problem No Code Available (3191)

Event Date 08/03/2013

Event Type  Injury  

Manufacturer Narrative

The controller ((b)(4)) was returned to the manufacturer for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.The returned controller continued to malfunction on the bench as described in the complaint event.The controller failure mode indicated that the user interface controller uic circuitry was stuck in a loop: it did not properly pass its start-up self-test; its display continually reset and sounded a medium-priority alarm.The driveline disconnect alarm did not function properly.The controller did reliably start and run the pump motor.The root cause of the reported event was uic circuit failure as a result of user error.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, including transportation.The instructions for use (ifu) and patient manual provide clear instructions to the user on proper usage and care of the hvad system.Moreover, the ifu provides instruction to further educate the patient about product safety, alarm management, and hvad support; additional guidelines instruct the user on how to detect and react to a "vad stop'.A "vad stopped" alarm will activate if the pump driveline is not connected to the new controller within 10 seconds.This alarm will resolve once the pump driveline is connected.(b)(4).

Event Description

This patient had the cable from one of the batteries to the controller become caught in the automatic door of a bus.After this, the controller screen went blank, and the plug indicator on the controller began flashing.In addition, a low alarm (fixed yellow) was seen.The patient went home as quickly as possible and plugged the controller into an ac outlet.Once plugged in, a medium alarm sounded, and the controller screen showed an introductory screen with hvad and serial number; but no rpm, no flow, and no parameters appeared.The patient then connected a different battery, and no alarms sounded.Per the report received, the pump never stopped running.The patient was confused and not sure what to do at this point, and was advised by the clinical specialist to take an ambulance to the closest center taking all his accessories with him.The ambulance trip took 4-4.5 hours, as the patient did not have a car, but the "working" battery never drained a significant amount and there were no patient issues.The device was exchanged with no reported patient injury.

• 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: nathalie nunez ; 14400 nw 60th avenue; miami lakes, FL 33014-3105 ; 3053641538
• MDR Report Key: 6058076
• MDR Text Key: 58416369
• Report Number: 3007042319-2016-03769
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/09/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 1401DE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2013
• Date Manufacturer Received: 08/09/2013
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention