BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOPRO2 EXTENSION CABLE

    MDR report key: 3912110 · Received May 13, 2014

    Report

    Report Number
    2242352-2014-00543
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. SINCE THIS IS AN OEM SUPPLIED DEVICE, A LOT HISTORY REVIEW IS NOT APPLICABLE. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THEY WERE TRYING TO CONNECT AND DISCONNECT THE HEMOPRO2 EXTENSION CABLE AND PULLED TOO HARD AND THE TIP OF THE COLLAR POPPED OFF. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285497 HEMOPRO2 EXTENSION CABLE ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC. VH-4030

    Patients

    Seq Age Sex Outcome Treatment
    1