BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 2128548 · Received June 13, 2011

    Report

    Report Number
    2242352-2011-00697
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 7, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL REPORTEDLY NOT BE RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION, THEREFORE, NO EVALUATION COULD BE PERFORMED. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO 2 (VH-4000) DEVICE HAD PROGRESSIVE DETERIORATION IN PERFORMANCE UNTIL IT DID NOT WORK. THE HARVESTER RESTED THE UNIT FOR 30 SECONDS TO COOL, BUT PERFORMANCE WAS STILL INTERMITTENT. A REPLACEMENT VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM (VH-3000) WAS USED TO COMPLETE THE PROCEDURE. THE PRODUCT IS NOT RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR VH-4000 25014863

    Patients

    Seq Age Sex Outcome Treatment
    1 NA