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

Catalog Number 1401DE

Device Problems Loss of Power (1475); Failure to Power Up (1476); Pumping Stopped (1503); Device Dislodged or Dislocated (2923)

Patient Problem Loss of consciousness (2418)

Event Date 02/26/2014

Event Type  Injury  

Event Description

Pending cn from clinician.

Manufacturer Narrative

The device is available for evaluation, but has not been received by the manufacturer.Additional information will be submitted within thirty (30) days of receipt.Product is in route.

Manufacturer Narrative

The heartware vad is used for treatment not diagnosis.The controller was returned for analysis.Visual examination found that a connector pin on power source one (1) was damaged.The kind of damage observed is consistent with damage caused by user while attempting to connect a power source onto the controller without properly aligning the mating parts and applying excessive force.The most likely root cause of the reported event is user error.An internal investigation has been opened by the manufacturer.The confirmed malfunction is related to the reported event.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 manufacturer's instructions for use (ifu) provides instructions for properly connecting the power sources.It instructs to line up the solid white arrow on the connector with the white dot on the controller.Gently push the cable into the controller.Do not twist the connector, but allow it to naturally lock in place.A successful connection will result in an audible click.The ifu cautions, "do not force connectors together without proper alignment.Forcing together misaligned connectors may damage the connectors." heartware is submitting this report as a result of remediation activities related to fda warning letter (b)(4), dated june 2, 2014, and pursuant to the provisions of 21 cfr part 803.This report may be based on information which heartware has not been able to investigate or verify prior to the required reporting date.The manufacturer will submit a supplemental report when new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: HEARTWARE® VENTRICULAR ASSIST SYSTEM
• Type of Device: CIRCULATORY ASSIST SYSTEM, CONTROLLER
• Manufacturer (Section D): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 310
• Manufacturer (Section G): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 310
• Manufacturer Contact: tatyana chorny ; 14400 nw 60th avenue; miami lakes, FL 33014-3105 ; 3053641476
• MDR Report Key: 3701052
• MDR Text Key: 4249803
• Report Number: 3007042319-2014-00210
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 02/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/11/2010
• Device Catalogue Number: 1401DE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/02/2014
• Initial Date FDA Received: 03/26/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2009
• 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; Required Intervention