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

Catalog Number 1650DE

Device Problems Device Issue (2379); Battery Problem (2885)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2015

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.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 that one of the patient's battery has an irregular cycle count.There were no impact or consequence for the patient reported.No additional information provided.

Manufacturer Narrative

It was reported a battery with an irregular cycle count.The battery, bat050740, was returned for evaluation.Various analyses were conducted and reviewed to evaluate the performance of the device in relation to the reported event.Failure analysis of the returned battery revealed that the device failed visual inspection due to a damaged connector's spring.This is an additional observation not related to the reported event and most likely due to the usage pattern of the device.Additionally, the battery failed functional testing due to an abnormally high max error and erroneous cycle count.The abnormally high max error and erroneous cycle count is most likely due to a communication error between the controller and battery.Log file analysis revealed multiple critical battery alarms; however, bat050740 was not involved in these alarms.Review of the data log files also confirmed that bat050740 with an incorrect value of 3375 cycles was written into flash memory, suggesting that a communication error occurred between controller and battery.Note: the controller in use, (b)(4) contained the old software (no smr upgrade).The most likely root cause of the reported event can be attributed to a communication error between the controller and battery.Heartware has opened an internal investigation to address communication errors.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- BATTERY
• 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: nathalie nunez ; 14400 nw 60 avenue; miami lakes, FL 33014-3105 ; 3053641538
• MDR Report Key: 6796638
• MDR Text Key: 82793055
• Report Number: 3007042319-2017-02674
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2015
• Device Catalogue Number: 1650DE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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: 42 YR
• Patient Weight: 100