FDA Adverse Event Malfunction Summary report: N

HEARTMATE II SYSTEM CONTROLLER

MDR report key: 2861469 · Received November 28, 2012

Report

Report Number: 2916596-2012-01128
Event Type: Malfunction
Date Received: November 28, 2012
Date of Event: August 10, 2012
Report Date: October 30, 2012
Manufacturer: THORATEC CORP.
Product Code: DSQ
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE EVAL OF THE RETURNED SYSTEM CONTROLLER CONFIRMED THE REPORT OF A RED HEART ALARM. THE CONTROLLER WOULD NOT OPERATE A PUMP IN IT'S RECEIVED CONDITION AND ALARMED WITH A RED HEART. THE INVESTIGATION REVEALED AN OPEN FUSE ON THE INNER CONTROLLER PRINTED CIRCUIT BOARD. THERE WAS ALSO FOREIGN RESIDUE OBSERVED ON THE CONNECTOR PINS OF THE PERCUTANEOUS BULKHEAD CONNECTOR. THE FUSE WAS REPLACED AND THE CONTROLLER FUNCTIONED AS EXPECTED. THE LOG FILE FROM THE RETURNED CONTROLLER WAS DETERMINED TO BE CORRUPT AND DID NOT ADD ANY ADDITIONAL INFO TO THE INVESTIGATION. THE FOREIGN SUBSTANCE OBSERVED IN THE BULKHEAD CONNECTOR CONTRIBUTED TO THE OPEN FUSE CONDITION. A REVIEW OF DEVICE HISTORY RECORDS FOR THIS SYSTEM CONTROLLER SHOWED NO DEVIATIONS FROM MFG OR QA SPECIFICATIONS. NO FURTHER INFO IS AVAILABLE. THE MFR IS CLOSING ITS FILE ON THIS EVENT.

Description of Event or Problem · 1

THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE HOSP REPORTED THAT THE PT EXPERIENCED A RED HEART ALARM. THE SYSTEM CONTROLLER WAS EXCHANGED AND THE PROBLEM RESOLVED. UPON INVESTIGATION OF THE SYSTEM CONTROLLER, THE MFR DISCOVERED A DAMAGED FUSE, WHICH RESULTED IN THE LOSS OF PUMP SUPPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	HEARTMATE II SYSTEM CONTROLLER	DSQ: SYSTEM CONTROLLER	DSQ	THORATEC CORP.	103696	115962

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR		Other