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 05/17/2015

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.The reported event was confirmed via visual inspection.Analysis of the device revealed that the device failed to meet specifications; the device failed visual inspection due to damage of the controller display.The confirmed malfunction is related to the reported event.The most likely root cause of the failure is contact of the controller with a hard surface, which likely contributed to the event.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.Per the instructions for use (ifu): always have a backup controller handy and, whenever possible, a care giver nearby when changing power sources or controllers.Be watchful for unusual changes in power or flow alarms for a period of time following equipment changes.Patients are instructed to always keep a spare controller available at all times.The patient manual includes instructions on care of the equipment and warns that damaged equipment should be reported to your vad coordinator and inspected.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 by the vad coordinator that the patient called on-call phone complaining of screen on controller having issues; watts and flow were gone.Patient presented to hospital for elective controller change with the vad coordinator present.The controller was exchanged and no effects to the patient was reported.

• 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
• Manufacturer (Section G): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 3105
• Manufacturer Contact: tatyana chorny ; 14400 nw 60th avenue; miami lakes, FL 33014-3105 ; 3053641476
• MDR Report Key: 5666621
• MDR Text Key: 45519028
• Report Number: 3007042319-2016-01986
• 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
• Report Date: 05/18/2015

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 Expiration Date: 09/30/2015
• Device Catalogue Number: 1403US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/18/2015
• Initial Date FDA Received: 05/19/2016
• 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