BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2 EVH SYSTEM

    MDR report key: 1931890 · Received November 30, 2010

    Report

    Report Number
    2242352-2010-03460
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 1, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A VISUAL INSPECTION REVEALED THAT THERE WERE MINIMAL SIGNS OF USAGE. THE HEATER ELEMENTS WERE BOWED OUT SLIGHTLY. THE DEVICE HAD MINIMAL EVIDENCE OF BLOOD. RESISTANCE MEASUREMENTS DID NOT PASS SPECIFICATIONS. A FUNCTIONAL TEST EVALUATING THE THERMAL SHUT-DOWN PERFORMANCE OF THE UNIT WAS PERFORMED ON THE RETURNED DEVICE USING A REFERENCE POWER SUPPLY AND CABLE. THE DEVICE DID NOT PERFORM AS EXPECTED DURING THE DEVICE ACTIVATION, IT WOULD NOT POWER UP. THE HANDLE WAS OPENED UP AND IT WAS OBSERVED THAT THE HEATER WIRE WAS DETACHED FROM THE SWITCH WELD. BASED UPON THIS OBSERVATION AND THE FUNCTIONAL TEST, THE REPORTED COMPLAINT FOR "STOPPED WORKING" WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE FIRST VASOVIEW HEMOPRO2 WORKED FOR ABOUT 3 ACTIVATIONS AND THEN WOULD NOT WORK ANYMORE. THE ADAPTOR WAS SWITCHED, BUT THE DEVICE STILL WOULD NOT WORK. THEN A NEW KIT WAS OPENED. THERE WERE NO PT EFFECTS REPORTED AS A RESULT OF THIS PRODUCT PROBLEM. THE PRODUCT WAS RETURNED.

    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 25021864

    Patients

    Seq Age Sex Outcome Treatment
    1 NA