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

Catalog Number 1403US

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2015

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 review of the device history record, it indicates that the device met all specification requirements prior to release.The reported event was confirmed via functional testing as well as damage to the overlay.The damage found to the overlay may be a result of the handling of the device multiple times as a training device.There is no indication fo any relationship to the manufacturing process.Therefore, will a review of all event details, available testing and data, the most likely root cause of the reported event is attributed ot the damaged overlay after multiple uses as a training device.The products was used for training equipment only and therefore not associated with any use with a patient.The instructions for use (ifu) and patient manual include a reference guide for both visual and tone alarms including potential causes and actions to take.Additionally there is 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 the controller battery indicator levels do not light up.A replacement was requested.The device was a training device and therefore had no impact on a 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 revealed that the controller had two reworks.The overlay was replaced in both reworks; however, it's unlikely this contributed to the event as the device met all requirements prior to 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.The alarm mute and scroll buttons were unresponsive.Additionally, the battery gauge showed no bars when two power sources were attached to both ports.Internal inspection revealed a damaged overlay, most likely due to the handling of the device.The most likely root cause of the reported event can be attributed to a damaged overlay.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 60 avenue; miami lakes FL 33014 3105
• Manufacturer (Section G): HEARTWARE, INC.; 14400 nw 60 avenue; miami lakes FL 33014 3105
• Manufacturer Contact: tatyana chorny ; 14400 nw 60 avenue; miami lakes, FL 33014-3105 ; 3053641476
• MDR Report Key: 5661011
• MDR Text Key: 45345774
• Report Number: 3007042319-2016-01980
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/19/2015

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 Catalogue Number: 1403US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/19/2015
• Initial Date FDA Received: 05/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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