BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2 EVH SYSTEM

    MDR report key: 2061487 · Received March 16, 2011

    Report

    Report Number
    2242352-2011-00144
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL REPORTEDLY NOT BE RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VH-4000 HEMOPRO 2 UNIT WOULD NOT ACTIVATE. THE CORDS WERE SWITCHED WITH NO SUCCESS. A SECOND UNIT WAS OPENED UP, BUT STILL WOULD NOT ACTIVATE. A VV6 UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE PRODUCTS ARE NOT RETURNING. THE HOSPITAL DID NOT PERFORM THE PRE-TEST. THE POWER SUPPLY SETTING WAS ON 3. THE CABLE HAD BEEN USED BEFORE BUT THEY DO NOT KNOW HOW MANY TIMES. THE TM WILL BE GOING TO THE HOSPITAL TO SEE IF THERE ANY PROBLEMS WITH THE POWER SUPPLY AND CORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO 2 EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-4000 25027541

    Patients

    Seq Age Sex Outcome Treatment
    1 NA