BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 14V POWER MODULE PATIENT CABLE

    MDR report key: 3822721 · Received February 11, 2014

    Report

    Report Number
    2916596-2014-00161
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Date of Event
    January 15, 2014
    Report Date
    January 15, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    USAGE OF THE DEVICE: THE USAGE OF THE RETURNED 14 VOLT POWER MODULE PT CABLE (LOT # 35087360612) IS NOT KNOWN TO THE MFR AS THE PT CABLE IS NOT LABELED FOR SINGLE USE. THE PT CABLE WAS RETURNED TO THE MFR FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE PERFUSIONIST REPORTED SEEING A SYSTEM CONTROLLER TIMER RESET EVENT ON THE PT HISTORY SCREEN. THE PERFUSIONIST SWAPPED OUT THE 14 VOLT POWER MODULE PT CABLE AND THE ISSUE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90303 HEARTMATE 14V POWER MODULE PATIENT CABLE DSQ: POWER MODULE PATIENT CABLE DSQ THORATEC CORP. 103426 35087360612

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention