BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOPRO2 EXTENSION CABLE

    MDR report key: 2181380 · Received July 7, 2011

    Report

    Report Number
    2242352-2011-00812
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 13, 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THERE WERE NO NON CONFORMITIES WITH THE CABLE. CURRENT OUTPUT MEASUREMENTS PASSED SPECS. A FUNCTIONAL TEST EVALUATING THE THERMAL SHUT-DOWN PERFORMANCE OF THE UNIT WAS PERFORMED ON THE RETURNED DEVICE USING A REFERENCE POWER SUPPLY AND HEMOPRO 2 TOOL. THE HARVESTING TOOL DEVICE PERFORMED ACCORDING TO SPECS DURING THE DEVICE ACTIVATION. BASED UPON THIS OBSERVATION, THE REPORTED COMPLAINT FOR "NO POWER" COULD NOT BE CONFIRMED. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO 2 WAS BEING USED ON A RADIAL HARVEST AND STOPPED WORKING. THIS OCCURRED ABOUT 1/4-1/2 THROUGH THE PROCEDURE; THE DISSECTION WENT FINE; BUT THEN AFTER SEVERAL BRANCH CUTS, THERE WERE NO BEEPS, OR SMOKE AND THE BRANCHES WERE NOT DIVIDING. THEY CLEANED THE JAWS AND RECONNECTED THE CORD, BUT THE DEVICE STILL WOULD NOT WORK. A REPLACEMENT VASOVIEW 7 BISECTOR KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOPRO2 EXTENSION CABLE CABLE GEI MAQUET CARDIOVASCULAR, LLC VH-4030 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA