BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE BATTERY CLIP

    MDR report key: 3822718 · Received February 20, 2014

    Report

    Report Number
    2916596-2014-00218
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    January 17, 2014
    Report Date
    January 23, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BATTERY CLIP WAS RETURNED TO THE MFR FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    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 WHEN THE PT WAS ATTEMPTING TO SWITCH FROM THE POWER MODULE TO BATTERIES IN THE MORNING, SHE COULD NOT GET THE BATTERY CLIP TO ENGAGE WITH THE SYSTEM CONTROLLER. SHE SET IT DOWN NEXT TO HER SO SHE COULD RE-EVALUATE THE SITUATION AND INADVERTENTLY DISCONNECTED HERSELF FROM BOTH POWER SUPPLIES. SHE HAD A PUMP STOP FOR LESS THAN 1 MIN WHEN SHE WAS ABLE TO REATTACH 1 POWER SOURCE AND BY THAT TIME HER HUSBAND HAD ARRIVED AND WAS ABLE TO FINALLY GET THE BATTERY CLIP TO ATTACH. THE PT WAS GIVEN A NEW BATTERY CLIP IN CLINIC. THE VAD COORDINATOR ATTEMPTED TO CONNECT THE SYSTEM CONTROLLER TO THE CLIP AND COULD NOT GET IT TO FULLY ENGAGE INTO THE LOCKED POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106817 HEARTMATE BATTERY CLIP DSQ: LVAD BATTERY CLIP DSQ THORATEC CORP. 2865 35110960812-A

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention