BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 3030570 · Received March 27, 2013

    Report

    Report Number
    2242352-2013-00288
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    January 28, 2013
    Report Date
    March 8, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICES ARE 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. A LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE PRODUCT LOT NUMBER IS UNK. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE SILICONE INSULATION ON THE HEMOPRO JAW SEPARATED. A REPLACEMENT DEVICE WAS USED AND THE SAME ISSUE OCCURRED. NOTHING FELL INTO THE PT AND NO INTERVENTION WAS REQUIRED. THE HOSPITAL REPORTED THAT THERE WAS SOME BLEEDING AT THE SITE; HOWEVER, IT WAS VERY MINIMAL AND A TRANSFUSION WAS NOT REQUIRED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. THE HOSPITAL WILL REPORTEDLY NOT BE RETURNING THE PRODUCTS IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125877 VASO VIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC. VH-3000 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA