BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 2802450 · Received October 18, 2012

    Report

    Report Number
    2242352-2012-01086
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Date of Event
    September 25, 2012
    Report Date
    September 25, 2012
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES HAVE NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVAL. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICES. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICES ARE RECEIVED. 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, ONE HEMOPRO 2 DEVICE SHORTED OUT AND STOPPED WORKING AND A SECOND DEVICE STOPPED CAUTERIZING AND BURNING. THE HOSP RESET THE SECOND DEVICE TWICE BY WAITING FOR 30 SECONDS; HOWEVER, IT STILL WOULD NOT CAUTERIZE. A THIRD REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT EFFECTS. THE HOSP INTENDS TO RETURN THE PRODUCTS IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-4000 25061966

    Patients

    Seq Age Sex Outcome Treatment
    1 NA