MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER AC ADAPTER; VENTRICULAR (ASSISST) BYPASS

Model Number 1430JP

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 03/01/2018

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 and destination therapy 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.Product event summary: the returned controller ac adapter passed functional tests but failed external visual inspection due to a damaged controller ac adapter inlet connector holder/clamp.Investigation is ongoing.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the metal cable holder clip on the controller ac adapter case was malformed.It was further reported that the clip was bent to one side.This issue was found during initial inspection of the device and prior to being assigned to a patient.The device was removed from service.There was no patient involvement.

Manufacturer Narrative

The controller ac adapter was returned for evaluation.A review of the manufacturing documentation confirmed that the associated device met all requirements for release.Failure analysis of the returned device revealed that the controller ac adapter passed functional testing.Visual inspection of the device and images provided by site revealed that the controller ac adapter metal inlet connector holder/clamp was damaged and unaligned.As a result, the reported event was confirmed.Based on the available information, the most likely root cause of the reported event can be attributed to an improper assembly during the manufacturing process.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER AC ADAPTER
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7845749
• MDR Text Key: 120109153
• Report Number: 3007042319-2018-04242
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1430JP
• Device Catalogue Number: 1430JP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Date Manufacturer Received: 09/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MCS UNKNOWN VAD