BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3853640 · Received April 3, 2014

    Report

    Report Number
    2916596-2014-00393
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Date of Event
    March 7, 2014
    Report Date
    March 7, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT OF A YELLOW WRENCH ADVISORY ALARM DUE TO A BACKUP BATTERY FAULT WAS CONFIRMED BASED ON THE EVALUATION OF THE LOG FILE DOWNLOADED FROM THE RETURNED SYSTEM CONTROLLER; HOWEVER, THE YELLOW WRENCH ALARM WAS NOT REPRODUCED DURING ANALYSIS OF THE SYSTEM CONTROLLER. ALTHOUGH THE YELLOW WRENCH ALARM WAS NOT REPRODUCED DURING THE ANALYSIS, A "NO EXTERNAL POWER" ALARM STATUS BECAME ACTIVE WHEN THE BLACK POWER CABLE OF THE SYSTEM CONTROLLER WAS DISCONNECTED. THE INVESTIGATION REVEALED ONE BENT PIN ON THE BACKUP BATTERY OF THE SYSTEM CONTROLLER, THAT DETECTS THE CONNECTION OF THE WHITE POWER CABLE, WAS CAUSING A ¿NO EXTERNAL POWER¿ ALARM WHEN DISCONNECTING THE BLACK POWER CABLE. IT SHOULD BE NOTED THAT ALTHOUGH THE YELLOW WRENCH ALARM WAS NOT REPRODUCED IT IS POSSIBLE FOR A BENT OR BROKEN PIN TO RESULT IN A YELLOW WRENCH ADVISORY ALARM. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATION THAT WOULD AFFECT DEVICE FUNCTION OR PERFORMANCE. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD).THE VAD COORDINATOR REPORTED THAT THE SYSTEM CONTROLLER WAS GIVEN TO THE PT AS A BACKUP. THE PT UNDERWENT A TRANSESOPHAGEAL ECHO AND HAD HIS SPEED ADJUSTED. WHEN HOOKING THE PT FROM BATTERY TO POWER MODULE TO ADJUST SPEED, A PUMP OFF ALARM WAS NOTED. THERE WAS A YELLOW WRENCH BACKUP BATTERY FAULT ON THE SYSTEM CONTROLLER. THE SYSTEM CONTROLLER WAS EXCHANGED AND THE ISSUE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203633 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106762 134583

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention