BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 2201726 · Received August 4, 2011

    Report

    Report Number
    2242352-2011-01046
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 9, 2011
    Report Date
    July 13, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. WE WILL CONTINUE PURSUING THE DEVICE BEING RETURNED BY THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. ITEMS MARKED "NI" ARE UNK TO US AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO 2 HAD EXCESSIVE SMOKE IN THE TUNNEL. THEY HAD TO DISCONNECT THE SCOPE FROM THE HARVESTING CANNULA AS VENTING HANDLES WERE NOT SUFFICIENT TO CLEAR SMOKE. THE REPORTED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PT EFFECTS. MAQUET CARDIOVASCULAR ANTICIPATES RETURN OF THE PRODUCT IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-4000 0300001524

    Patients

    Seq Age Sex Outcome Treatment
    1 NI