MAUDE Adverse Event Report: HEARTWARE, INC HEARTWARE® VENTRICULAR ASSIST SYSTEM - CONTROLLER 1.0; CIRCULATORY ASSIST SYSTEM

Catalog Number 1407DE

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/29/2016

Event Type  malfunction  

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.Analysis of the device revealed that the device failed to meet specifications; the device failed visual inspection as a result of the serial data port cover found missing, confirming the reported event.The missing serial port cap was most likely due to improper handling of the device.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.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.This event was assessed and is being reported as part of a retrospective review of events, which was in response to an update to the mdr decision criteria.

Event Description

It was reported by the patient that the data connection port cover of the controller was missing.  the controller was exchanged without consequence to the patient.  no further information was provided.

• Brand Name: HEARTWARE® VENTRICULAR ASSIST SYSTEM - CONTROLLER 1.0
• 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: 6921213
• MDR Text Key: 89363055
• Report Number: 3007042319-2017-03584
• 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
• Report Date: 02/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2015
• Device Catalogue Number: 1407DE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2014
• 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