BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 14V POWER MODULE PATIENT CABLE

    MDR report key: 3113857 · Received May 7, 2013

    Report

    Report Number
    2916596-2013-00570
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    January 25, 2013
    Report Date
    April 9, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    USAGE OF THE DEVICE: THE USAGE OF THE RETURNED POWER MODULE 14 VOLT PT CABLE (LOT # 35087360412; MFG DATE JUNE 2012) IS NOT KNOWN TO THE MFR AS THE PT CABLE IS NOT LABELED FOR SINGLE USE. THE SUSPECT 14 VOLT POWER MODULE PT CABLE WAS RETURNED TO THE MFR FOR ANALYSIS AND THE REPORTED EVENT WAS CONFIRMED. THE RETURNED 14 VOLT POWER MODULE PT CABLE WAS CONNECTED TO A MOCK CIRCULATORY LOOP IN OUR LAB AND A CRITICAL FAULT ALARM (RED BATTERY HAZARD AND YELLOW WRENCH INDICATORS) WAS OBSERVED ON THE POWER MODULE. THE TEST SYSTEM CONTROLLER ALSO INDICATED "POWER CABLE DISCONNECTED" AND LOW VOLTAGE (YELLOW BATTERY) ALARMS. ALTHOUGH POWER TO THE TEST PUMP WAS NOT INTERRUPTED, PUMP TELEMETRY DATA WAS NOT DISPLAYED ON THE SYSTEM MONITOR SCREEN. FURTHER EXAMINATION OF THE 14 VOLT POWER MODULE PT CABLE CONFIRMED COMPROMISED INNER CONDUCTORS IN THE 18-FOOT SECTION OF THE CABLE CLOSE TO THE Y-JUNCTION STRAIN RELIEF. THE COMPROMISED WIRES WERE IDENTIFIED AS THE MONITORING AND COMMUNICATION LINES WHICH CAUSED THE INTERRUPTION OF COMMUNICATION BETWEEN THE POWER MODULE, SYSTEM CONTROLLER AND SYSTEM MONITOR. THE COMPROMISED CONDUCTORS ALSO RESULTED IN THE SHORT CIRCUIT OF THE WIRES TO THE BRAIDED SHIELD CAUSING A CRITICAL FAULT ALARM ON THE POWER MODULE AND SYSTEM CONTROLLER. THE SHORT COULD HAVE CONTRIBUTED TO THE INTERRUPTION IN PUMP FUNCTION AS WAS REPORTED AND OBSERVED DURING THE INTERROGATION OF THE VAD PARAMETERS AT THE HOSPITAL. THE CAUSE OF THE WIRE CONDUCTOR BREAKDOWN APPEARED TO BE RELATED TO WEAR AND TEAR OVERTIME DUE TO REPETITIVE FLEXING. NO FURTHER INFO IS AVAILABLE. THE MFR IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT THE PT PRESENTED TO THE HOSPITAL DUE TO ISSUES WITH THE POWER MODULE AND SYSTEMS CONTROLLER. THE PT WAS REPORTEDLY UNABLE TO PERFORM A SELF TEST ON THE SYSTEM CONTROLLER AND THE RED BATTERY HAZARD AND YELLOW WRENCH SYMBOLS ON THE POWER MODULE WERE ILLUMINATED. DURING THE VAD INTERROGATION WERE THE PT WAS AT THE CLINIC, THE VAD COORDINATOR REPORTEDLY NOTICED A PUMP STOP. THE PT WAS PROVIDED ANOTHER POWER MODULE AND THE 14 VOLT POWER MODULE PT CABLE WAS ALSO EXCHANGED. ACCORDING TO THE INFO PROVIDED BY THE HOSPITAL, THE SYSTEM CONTROLLER IN USE WITH THE PT AT THE TIME OF THIS EVENT REMAINS IN USE WITH PT. THE PT CONTINUES ON LVAD SUPPORT WITH NO FURTHER ISSUE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198044 HEARTMATE 14V POWER MODULE PATIENT CABLE DSQ: POWER MODULE PATIENT CABLE DSQ THORATEC CORP. 103426 35087360412

    Patients

    Seq Age Sex Outcome Treatment
    1 Other