BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 3252431 · Received July 24, 2013

    Report

    Report Number
    2242352-2013-00688
    Event Type
    Malfunction
    Date Received
    July 24, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 2, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVAL. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE HEMOPRO FAILED TO DEACTIVATE. THE VEIN THAT WAS HARVESTED WAS UNABLE TO BE USED AND AN ADDITIONAL VEIN HAD TO BE UTILIZED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSP INTENDS TO RETURN THE HEMOPRO DEVICE AND EXTENSION CABLE. PLEASE REFER TO 2242352-2013-00689 FOR THE EXTENSION CABLE THAT WAS USED IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345637 VASO VIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25076371

    Patients

    Seq Age Sex Outcome Treatment
    1 NI