BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 14V POWER MODULE PATIENT CABLE

    MDR report key: 2922170 · Received January 16, 2013

    Report

    Report Number
    2916596-2013-00069
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    USAGE OF THE DEVICE: THE USAGE OF THE RETURNED POWER MODULE 14 VOLT PATIENT CABLE (LOT # 34756240210; MFG DATE AUGUST 2010) IS NOT KNOWN TO THE MANUFACTURER, AS THE PATIENT CABLE IS NOT LABELED FOR SINGLE USE. THE SUSPECT POWER MODULE 14 VOLT PATIENT CABLE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS AND THE REPORTED EVENT WAS CONFIRMED. THE RETURNED POWER MODULE 14 VOLT PATIENT CABLE WAS CONNECTED TO A MOCK CIRCULATORY LOOP IN OUR LAB AND WE OBSERVED A "POWER CABLE DISCONNECTED" ADVISORY ALARM ON THE TEST SYSTEM CONTROLLER AND ON THE SYSTEM MONITOR SCREEN. WHEN THE MOCK CIRCULATORY LOOP WAS OPERATED SOLELY ON THE WHITE POWER LEAD OF THE RETURNED POWER MODULE 14 VOLT PATIENT CABLE, A POWER LOSS TO THE SYSTEM CONTROLLER OCCURRED AND THE TEST PUMP STOPPED. FURTHER EVALUATION OF THE WHITE POWER LEAD REVEALED THAT THE REDUNDANT POWER LINES WERE COMPROMISED ADJACENT TO THE Y-JUNCTION AND AT THE POWER LEAD CONNECTOR END. THE COMPROMISED REDUNDANT POWER LINES CONTRIBUTED TO A LOSS OF VOLTAGE SUPPLY TO THE SYSTEM CONTROLLER AND SUBSEQUENT INTERRUPTION OF PUMP FUNCTION. THE CAUSE OF THE WIRE CONDUCTOR BREAKDOWN APPEARED TO BE RELATED TO WEAR AND TEAR OVERTIME DUE TO REPETITIVE FLEXING. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THE PATIENT PRESENTED TO THE CLINIC WITH COMPLAINTS OF LOW FLOW ALARMS WHILE CONNECTED TO THE POWER MODULE (TETHERED SUPPORT). NO ALARMS WERE REPORTEDLY OBSERVED WHILE THE PATIENT WAS CONNECTED TO BATTERY POWER. WHILE THE PATIENT WAS IN THE CLINIC, THE VAD COORDINATOR REVIEWED THE LOG FILE DATA ON THE SYSTEM MONITOR SCREEN AND NOTED MULTIPLE LOW FLOW ALARMS AS WELL AS A TIME CLOCK RESET STAMP CONSISTENT WITH A POWER INTERRUPTION TO THE SYSTEM CONTROLLER. THE LOG FILE DATA SUBMITTED TO THE MANUFACTURER FOR REVIEW REVEALED REDUCTION IN VOLTAGE LEVELS WHICH APPEARED TO INDICATE A PROBLEM WITH THE PATIENT'S POWER MODULE PATIENT CABLE. THE MANUFACTURER RECOMMENDED THAT THE POWER MODULE 14 VOLT PATIENT CABLE SHOULD BE EXCHANGED. NO FURTHER ALARMS WERE OBSERVED AFTER THE SUSPECT POWER MODULE 14 VOLT PATIENT CABLE WAS EXCHANGED AND THE PATIENT CONTINUES ON LVAD SUPPORT WITH NO FURTHER ISSUE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23896 HEARTMATE 14V POWER MODULE PATIENT CABLE DSQ: POWER MODULE PATIENT CABLE (14 VOLT) DSQ THORATEC CORP. 103426 34756240210

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other