BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II 14V LI-ION BATTERY CLIP

    MDR report key: 2193522 · Received July 21, 2011

    Report

    Report Number
    2916596-2011-00305
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PAIR OF BATTERY CLIPS WAS RETURNED TO THE MFR FOR EVAL. THE ANALYSIS OF THE BATTERY CLIPS CONFIRMED THE REPORTED EVENT OF THE METAL PORTION OF THE BATTERY CLIP HAD LIFTED; HOWEVER, THE REPORT OF A LOOSE BATTERY CAUSING THE PUMP TO STOP WAS NOT CONFIRMED. DURING THE VISUAL EVAL OF ONE OF THE BATTERY CLIPS, THE INTERIOR OF THE CLIP REVEALED THE CONTACT PRINTED CIRCUIT BOARD ASSEMBLY LOCATED IN THE BATTERY CLIP HOUSING WAS SLIGHTLY OUT OF PLACE. THE LEMO CONNECTORS WERE PROPERLY SEATED AND ALIGNED WITHIN THEIR RESPECTIVE SOCKETS. FURTHER EXAMINATION REVEALED DAMAGE TO THE LEMO CONNECTORS OF BOTH CLIPS THAT APPEARED TO BE CAUSED BY THE PINS OF THE MATING SYSTEM CONTROLLER CONNECTORS. ONE CLIP HAD A BROKEN PIN FROM THE SYSTEM CONTROLLER LODGED IN THE LEMO CONNECTOR. IT WAS NOTED THAT THE SYSTEM CONTROLLER WAS NOT RETURNED FOR EVAL. A TEST BATTERY WAS INSERTED IN EACH OF THE CLIPS AND WAS FOUND TO BE UNREMARKABLE. THE BATTERY REMAINED SECURED IN BOTH CLIPS WHEN MANIPULATED. THE BATTERY RELEASE MECHANISMS WERE CHECKED AND WERE UNREMARKABLE. THE BATTERY CLIPS WERE FUNCTIONALLY TESTED UNDER NORMAL OPERATING CONDITIONS AND FUNCTIONED AS INTENDED. THE BATTERIES INSIDE THE BATTERY CLIPS AND THE CONNECTIONS BETWEEN THE TEST SYSTEM CONTROLLER AND THE BATTERY CLIP WERE MANIPULATED WHILE THE SYSTEM WAS RUNNING ON THE TEST MOCK LOOP WITH NO ALARMS NOTED AND THE SYSTEM CONTINUED TO OPERATE AS INTENDED. THE BATTERY CLIPS WERE DISASSEMBLED AND THE PRINTED CIRCUIT BOARD ASSEMBLY WAS MEASURED AND ALL MEASUREMENTS WERE WITHIN SPEC. NO FURTHER INFO IS AVAILABLE. THE MFR IS NOW CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT A LOOSE BATTERY IN THE BATTERY CLIP CAUSED THE PT'S LVAD PUMP TO STOP. IT WAS NOTED THAT THE METAL PORTION OF THE BATTERY CLIP HAD LIFTED. THE PT WAS GIVEN A NEW SET OF BATTERY CLIPS FROM THE HOSPITAL'S INVENTORY AND NO FURTHER PROBLEMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II 14V LI-ION BATTERY CLIP 14 VOLT LI-ION BATTERY CLIP DSQ THORATEC CORP. 2865 34483780208

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention