FDA Adverse Event Malfunction Summary report: N

HEARTWARE® VENTRICULAR ASSIST SYSTEM

MDR report key: 3854431 · Received June 6, 2014

Report

Report Number: 3007042319-2014-00584
Event Type: Malfunction
Date Received: June 6, 2014
Date of Event: July 15, 2013
Report Date: May 7, 2014
Manufacturer: HEARTWARE, INC
Product Code: DSQ
PMA / PMN Number: P100047
Removal / Correction Number: Z-1607-2014
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE BATTERIES WERE RETURNED; VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. THOROUGH EXTERNAL VISUAL INSPECTION OF THE BATTERIES REVEALED NO SIGNS OF PHYSICAL DAMAGE OR CONTAMINATION. FUNCTIONAL TESTING REVEALED THAT FOUR OF THE RETURNED BATTERIES CONTAINED A FAULTY CELL PAIR, WHICH MOST LIKELY CONTRIBUTED TO THE REPORTED EVENT. AN INTERNAL INVESTIGATION (CAPA) HAS BEEN OPENED TO ADDRESS THE ISSUE. THIS EVENT RELATES TO THE FSCA (B)(4) ISSUED BY HEARTWARE, INC. FOR THIS MATTER. THIS IS ONE OF FOUR REPORTS (3007042319-2014-00584, 00585, 00586, AND 00587) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

Description of Event or Problem · 1

APPROXIMATELY TWELVE MONTHS POST HVAD IMPLANTATION, THE SITE REPORTED THAT THE PATIENT EXPERIENCED POWER SOURCE CHANGE IN THE CONTROLLER EARLIER THAN EXPECTED. THE BATTERY WAS REMOVED FROM THE PATIENT AND A NEW BATTERY WAS SUPPLIED. NO HARM OR INJURY TO THE PATIENT WAS REPORTED AS A RESULT OF THIS INCIDENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
332748	HEARTWARE® VENTRICULAR ASSIST SYSTEM	CIRCULATORY ASSIST SYSTEM, BATTERY	DSQ	HEARTWARE, INC

Patients

Seq	Age	Sex	Outcome	Treatment
1				BAT025310- BATTERY\| BAT027568- BATTERY\| BAT025247- BATTERY\| BAT025313- BATTERY\| BAT025312- BATTERY