BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE POWER MODULE PATIENT CABLE, 14 VOLT

    MDR report key: 12092697 · Received June 30, 2021

    Report

    Report Number
    2916596-2021-03686
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Date of Event
    September 3, 2020
    Report Date
    June 30, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010784
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THE PMA # PROVIDED IS ASSOCIATED WITH MOST RECENT APPROVAL. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT, OF A FAULTY POWER MODULE PATIENT CABLE, WAS CONFIRMED WHEN THE CABLE WAS OPERATIONALLY CHECKED AND PHYSICALLY EXAMINED. THE OPERATING VOLTAGES FROM THE POWER MODULE WITH THE PATIENT CABLE WERE LOW (APPROXIMATELY 13 VDC) WHEN THE CABLE WAS USED WITH A MOCK LOOP LOAD. THE TYPICAL VOLTAGES ARE 14 VDC OR GREATER. THESE LOW OPERATING VOLTAGES ARE INDICATIVE OF A FAULTY PATIENT CABLE. THE PATIENT CABLE FAILED ELECTRICAL RESISTANCE CHECKS ¿ ALL LINES. THE POWER CABLE LEADS AND ALMOST THE ENTIRE LENGTH OF THE CABLE'S INTERNAL WRAPPINGS WERE GREEN COLORED ¿ INDICATIVE OF MOISTURE INGRESS AND CORROSION DAMAGE. THERE WAS NO OBVIOUS MECHANICAL DAMAGE TO THE OUTER JACKET OF THE CABLE (CUTS, SCUFF MARKS OR KINKS). THERE WAS NO OBVIOUS DAMAGE TO THE INTERNAL WIRES WHEN THE CABLE WERE EXAMINED (CUT OPEN). THE CABLE WAS APPROXIMATELY 4 YEARS OLD AND BEYOND THE RECOMMENDED USAGE LIFE (ANNUAL REPLACEMENT). THE CAUSE OF THE DAMAGE WAS LIKELY WEAR-RELATED AND CONDUCTOR BREAKDOWN OF THE PATIENT CABLE. SYSTEM CONTROLLER WARNINGS, ALARMS AND THE ACTIONS TO BE TAKEN AS A RESULT OF THE ALARMS ARE DESCRIBED IN THE HEARTMATE II LVAS PATIENT HANDBOOK (REV G P.213 ¿ ALARMS AND TROUBLESHOOTING; P.219 ¿ LOW BATTERY ALARMS). INSPECTION POWER MODULE PATIENT CABLES FOR ANY SIGNS OF DAMAGE IS DOCUMENTED IN THE HEARTMATE POWER MODULE INSTRUCTIONS FOR USE (REV B P. 48 - ROUTINE INSPECTION). THE IFU ALSO SPECIFIES THAT THE PATIENT CABLE SHOULD BE REPLACED ANNUALLY AS PART OF SERVICE MAINTENANCE (REV B P. 49 ¿ ROUTINE MAINTENANCE). DEVICE BUILD INFORMATION ON THE PATIENT CABLE ASSEMBLY (PN 106846) IS AVAILABLE FROM THE APPROVED SUPPLIER (FOR THE PART). THE MANUFACTURING LOT # OF THE CABLE WAS LOT # 110 1708 1101. THE DATE ON THE LABEL WAS OCT 2017. PATIENT CABLES (PN 106846) WITH LOT# 110 1708 1101 WERE RECEIVED ON OCT 4, 2017. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CABLE HAD A FRAYED WIRE. THERE WAS NO PATIENT INVOLVEMENT. UPON INVESTIGATION OF THE RETURNED PATIENT CABLE, EVIDENCE OF FLUID INGRESS WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990772 HEARTMATE POWER MODULE PATIENT CABLE, 14 VOLT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 103426 11017081101 00813024010784

    Patients

    Seq Age Sex Outcome Treatment
    1