MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0; VENTRICULAR (ASSISST) BYPASS

Model Number 1420

Device Problems Device Inoperable (1663); Connection Problem (2900); Power Problem (3010)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/07/2018

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 and destination therapy 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.Other devices involved in this event: heartware ventricular assist system ¿ battery.Battery / (b)(4) / model #: 1650 / expiration date: 2018-05-31.Udi #: (b)(4).Mfg date: 2017-05-31.(b)(4).Heartware ventricular assist system ¿ battery.Battery / (b)(4) / model #: 1650 / expiration date: 2018-05-31.Udi #: (b)(4).Mfg date: 2017-05-31.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that power switching occurred with two batteries.It was also reported that a beep and a power disconnect occurred, causing the controller to lose power.A lubrication servicing procedure was conducted on the two batteries.The controller and two batteries remain in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

One (1) controller (b)(4) and two (2) batteries (bat554937, bat554903) were not returned for evaluation.Log file analysis was not conducted since log files were not available.As a result, the reported event could not be confirmed.A power source lubrication procedure was performed to mitigate the reported conditions and the batteries remain in use.Applicable risk documentation and experience with events of similar circumstances were considered; a possible root cause of the reported premature power switching events can be attributed to communication errors and/or momentary disconnections between the controller and batteries.However, the reported beeps are most likely attributed to momentary disconnections between the controller and batteries.A possible root cause of the loss of power can be attributed to a disconnection of both power sources and/or to an intermittent disconnection on one or both power sources.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7658031
• MDR Text Key: 113265738
• Report Number: 3007042319-2018-02826
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1103 VAD
• Patient Age: 59 YR
• Patient Weight: 83