BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO

    MDR report key: 3770383 · Received January 24, 2014

    Report

    Report Number
    2242352-2014-00013
    Event Type
    Malfunction
    Date Received
    January 24, 2014
    Date of Event
    December 31, 2013
    Report Date
    January 2, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NON-CONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE PA WAS SETTING UP THE VASOVIEW HEMOPRO FOR USE TO HARVEST THE VEIN AND DID NOT NOTICE ANYTHING WRONG. WHILE INFLATING THE CUFF OF THE TROCAR DURING VEIN DISSECTION, IT WAS OBSERVED THAT THE CUFF WOULD NOT INFLATE AT ALL. THE AIR ESCAPED AS IT WAS INFLATING. THEY PROCEEDED WITH THE CASE USING THAT TROCAR IN THE INCISION WITHOUT CUFF INFLATION. THE SAME 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
    57350 VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25087458

    Patients

    Seq Age Sex Outcome Treatment
    1 NI