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

Catalog Number 1407IT

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/31/2016

Event Type  malfunction  

Manufacturer Narrative

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 instructions for use (ifu) and patient manual include a warning to keep spare, fully charged batteries and back up controller available at all time.The steps for exchange of batteries and controllers are outlined.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.

Event Description

It was reported that there was an issue with the 1st led light of the port 1 of the controller.Two fully-charged batteries were connected to port 1 and saw the 1st light was still out.The same fully-charged batteries gave 4 led lights on port 2 but only 3 led lights in port 1: it was confirmed that the 1st led light of the controller port 1 is malfunctioning.The controller was exchanged with a new one with no effect to the patient.

Manufacturer Narrative

One controller was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.Review of the manufacturing documentation confirmed that the associated device met all requirements for release.The reported event was confirmed via functional testing.Analysis of the device revealed that the device failed to meet specifications; the device passed visual examination but failed functional testing due to an led on the battery 1 gas gauge which would not illuminate.Internal visual inspection revealed a missing resistor (r17), which most likely fell off the controller pcba due to defective solder joints.R17 is a current limiter for the first led for ps1 in the controller.Replacing the missing resistor (r17) restored full functionality to the controller's display.The most likely root cause of the reported event can be attributed to a soldering defect 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: nathalie nunez ; 14400 nw 60th avenue; miami lakes, FL 33014-3105 ; 3053641538
• MDR Report Key: 5635592
• MDR Text Key: 44562877
• Report Number: 3007042319-2016-01892
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: 1407IT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/11/2016
• Initial Date FDA Received: 05/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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 Age: 57 YR
• Patient Weight: 75