BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT CABLE

    MDR report key: 10503517 · Received September 8, 2020

    Report

    Report Number
    2916596-2020-04245
    Event Type
    Malfunction
    Date Received
    September 8, 2020
    Date of Event
    August 13, 2020
    Report Date
    November 12, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION, THE PATIENT'S SHORT TO SHIELD WAS PREVIOUSLY REPORTED UNDER MANUFACTURER REPORT NUMBER 2916596-2020-00735. THIS EVENT ONLY COVERS THE PREVENTATIVE REPLACEMENT OF THE PATIENT CABLE. THEREFORE THE MANUFACTURER NO LONGER CONSIDERS THIS A REPORTABLE EVENT, AS NO NEW DRIVELINE DAMAGE WAS REPORTED. SECTION H4: ADDITIONAL INFORMATION. MANUFACTURER'S INVESTIGATION CONCLUSION: THE PATIENT¿S 14V UNGROUNDED PATIENT CABLE WAS PREVENTATIVELY REPLACED. NO DEVICE ISSUES WERE REPORTED. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR UNGROUNDED PATIENT CABLE, SERIAL NUMBER (B)(6), WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) AND PATIENT HANDBOOK BOTH ADDRESS HOW TO PROPERLY CARE FOR, MAINTAIN, AND STORE THE EQUIPMENT FOR PROPER USE AND ALSO STATE THAT THE PATIENT CABLE MUST BE REPLACED 12 MONTHS AFTER INITIAL USE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED. PMA/510(K) #: P160054.

    Description of Event or Problem · 1

    THE PATIENT HAS A KNOWN SHORT TO SHIELD. THE PATIENT HAS BEEN MANAGING THIS WITH AN UNGROUNDED 14V CABLE. THE PATIENT WAS SEEN IN THE CLINIC AND THE CABLE WAS PREVENTATIVE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    969406 PATIENT CABLE VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 103426 7233540

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR