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

Catalog Number 1403US

Device Problems Image Display Error/Artifact (1304); Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2016

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) 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 will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.

Event Description

The instructions for use and patient manual include a warning to keep a spare back up controller available at all times and outlines that if there is a controller failure, the controller should be switched to the back-up controller.The steps for exchange of devices are also outlined.It further warns that damaged equipment should be reported to the manufacturer and inspected.

Manufacturer Narrative

It was reported that this patient's controller was noted to have one loose power port connecter (on the controller housing) and the lcd display on the controller was fading.  there was  no reported damage done to unit and no alarms.  the controller was exchanged without consequence to the patient.  no further information was provided.  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.A review of the device's incoming inspection records indicated that the unit met the internal requirements prior to its quality assurance release process.The reported event (loose component) was confirmed at the bench level.The controller failed visual inspection but passed functional testing.Both power ports and serial port connectors are loose from the controller housing.The narrative in the event details stating, "display on lcd screen is also fading" could not be verified at the bench level after running for approximately 2 hours.A possible root cause of the loose connector may be attributed to a shift in the manufacturing process.Heartware has an open internal investigation to evaluate the anomalies of loose connectors.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.

Manufacturer Narrative

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

• 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
• MDR Report Key: 6081721
• MDR Text Key: 59301930
• Report Number: 3007042319-2016-03974
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707000116
• UDI-Public: 010088870700011611150121
• Combination Product (y/n): N
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2018

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: 01/21/2016
• Device Catalogue Number: 1403US
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/27/2016
• Initial Date Manufacturer Received: 10/13/2016
• Initial Date FDA Received: 11/07/2016
• Supplement Dates Manufacturer Received: Not provided; 10/19/2018
• Supplement Dates FDA Received: 02/16/2017; 10/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: FSCA APR2016
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 77