BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3850441 · Received May 15, 2014

    Report

    Report Number
    2916596-2014-00700
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. DURING A ROUTINE DEVICE INTERROGATION, THE VAD COORDINATOR NOTED "SYSTEM CONTROLLER CELL LOW", "LOW VOLTAGE", "LOW VOLTAGE ADVISORY", AND "WARNING: LOW SPEED OPERATION" ALARMS ON THE HISTORY SCREEN. ALL OF THESE ALARMS CONDITIONS WERE PRECEDED BY "POWER CABLE DISCONNECT" ALARMS. THE PT REPORTED THAT SHE WAS SWITCHING FROM POWER MODULE TO BATTERY AT THE RECORDED TIMES. THE LOG FILE INDICATED THAT THERE WAS A LOW VOLTAGE HAZARD EVENT ASSOCIATED WITH AN EMERGENCY BACKUP BATTERY IN USE EVENT. IT APPEARED THAT POWER WAS SOON RESTORED AND SYSTEM VOLTAGE RETURNED TO WITHIN NORMAL OPERATING RANGE. THER WAS NO MOTOR STOPPED EVENT OR LOW SPEED HAZARD RECORDED. ANOTHER LOW VOLTAGE HAZARD WAS RECORDED AND THE SYSTEM VOLTAGE WAS RESTORED AND THE SYSTEM RETURNED TO NORMAL OPERATION. THE PT THEN BEGAN EXPERIENCING INTERMITTENT AUDIBLE ALARMS WHILE CONNECTED TO THE POWER MODULE AND 14 VOLT BATTERIES. THE ALARMS COULD BE REPRODUCED BY THE PT WHEN SHE MANIPULATED THE BLACK CABLE ON THE SYSTEM CONTROLLER. THE PT WAS AT HOME "MOVING HER BED AND FLIPPING HER MATTRESS WHEN SHE HEARD ALARMS ON HER SYSTEM CONTROLLER WHILE CONNECTED TO THE POWER MODULE." THE PT WAS READMITTED TO THE IMPLANTING CENTER. AN INTERROGATION OF HER SYSTEM CONTROLLER REVEALED "MULTIPLE LOW FLOW ALARMS." MORE LOG FILES SUBMITTED CONFIRMED PUMP STOPPED EVENTS WHILE CONNECTED TO THE POWER MODULE. THE PT RECEIVED A PUMP EXCHANGE ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291573 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ:LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 126230

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention