MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM-CONTROLLER 1.0; VENTRICULAR (ASSISST) BYPASS

Model Number 1403US

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/05/2017

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.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that there was a loose connection to the controller.There were several power disconnect alarms over a two day period, which resolved when the patient pushed the battery into the controller port.The controller was exchanged.The patient is a participant in the vad destination therapy trial improved blood pressure management clinical study.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the controller was not returned for evaluation.A review of the manufacturing records confirmed that the associated device met all requirements for release.Log file analysis was not conducted since log files were not available.Failure analysis of the device was not performed since the unit was not returned.As a result, the reported event could not be confirmed.Applicable risk documentation and experience with events of similar circumstances were considered; events with loose connection to the controller can be attributed, but not limited to, a forced or improper connection, damaged output connector and/or due to the handling of the device.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM-CONTROLLER 1.0
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7280985
• MDR Text Key: 100398152
• Report Number: 3007042319-2018-00685
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1403US
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1103 VAD
• Patient Age: 75 YR
• Patient Weight: 63