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

Model Number 1650DE

Device Problem Battery Problem (2885)

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

Event Date 06/02/2015

Event Type  malfunction  

Manufacturer Narrative

Product event summary: it was reported that the patient experienced critical battery alarms involving (b)(4).A retrospective remediation, documented under (b)(4), was initiated to ensure that all in-scope events are appropriately reassessed and retrospectively mdr reported.The shelf life requirement, for the ventricular assist device (vad) battery pack, is one (1) year from the manufacturing date.As a result, and upon further review of the investigation, it was determined that the batteries related to this complaint have been in storage for longer than one (1) year from the last time of use and are not suitable for testing.An extended storage period greater than one (1) year can cause the batteries to irreversibly degrade in performance that can lead to erroneous test results.Additionally, lithium-ion batteries in storage for prolong periods of inactivity may pose a safety risk.Therefore, the investigation will be conducted with relevant available information.A review of the batteries' manufacturing records confirmed that the associated devices met all requirements for release.The reported event was confirmed via review of the controller log files, which revealed one (1) critical battery alarm involving (b)(4) and one (1) critical battery alarm involving (b)(4).In each instance, the batteries went from a high relative state of charge (rsoc) to 0% rsoc.This is indicative of a communication errors between the controller and batteries.The most likely root cause of the reported event can be attributed to communication errors between the controller and batteries.Communication errors were investigated internally.Of note, the controller, (b)(4), in use during the event did not have the software master record (smr) upgrade.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.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.Additional products: battery (b)(4), expiration date: 2015-12-3,1 (b)(4), return date: 2015-06-16, evaluated by mfr, mfg date: 2014-12-31.

Event Description

It was reported that the controller displayed critical battery alarms for two different batteries.Both batteries were replaced.No patient complications have been reported as a result of this event.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7154913
• MDR Text Key: 96621870
• Report Number: 3007042319-2017-05518
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/29/2017

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: 10/31/2015
• Device Model Number: 1650DE
• Device Catalogue Number: 1650DE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2017
• Initial Date FDA Received: 12/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-1731-2015
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 52