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

Catalog Number 1650DE

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2015

Event Type  malfunction  

Manufacturer Narrative

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.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.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 from the site by the vad coordinator that in the week prior to the event, battery ((b)(4)) was fully charged, but after 5 minutes of use, the battery indicator on the controller went from 4 green bars, to 2 orange bars.Subsequently, the patient was using this battery again on sunday (b)(6) when he attached this battery as back up battery to his controller and used a different battery as primary battery on his controller.At a sudden moment the primary battery went empty (25 % of charge) and the caregiver of the patient wanted to exchange this battery.Patient disconnected the primary battery, but the controller did not switch to the back-up battery.It is unknown whether the controller alarmed and the controller stopped and the patient fainted and experience a short loss of consciousness, but recovered after support was reestablished through reconnection of the battery by the patient's wife.After the caregiver attached as soon as possible a new battery to the controller, and the problem disappeared.Patient exchanged to the back-up battery.It was stated that the log files were sent in for analysis.Patient remains at home with no effects after the event.No additional information provided.No further investigation needed.

Manufacturer Narrative

One controller was not returned for evaluation.Review of the manufacturing documentation confirmed that the associated controller met all requirements for release.One battery 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 met specifications; the device passed visual examination and functional testing.The reported event was confirmed via review of the controller log files, which revealed a controller power-up and motor start event on (b)(6) 2015, indicating both power sources were disconnected.In addition, there were several occurrences of premature power switching events prior to the 25% threshold involving batteries (b)(4).These premature switching events were most likely caused by a communication error between the controller and batteries.Heartware has opened an internal investigation to address this issue.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 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: 5433804
• MDR Text Key: 38130683
• Report Number: 3007042319-2016-00647
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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,Followup
• Report Date: 11/29/2015

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: 04/30/2016
• Device Catalogue Number: 1650DE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/15/2016
• Initial Date FDA Received: 02/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/14/2016
• 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
• Patient Age: 48 YR
• Patient Weight: 81