BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 3843239 · Received March 14, 2014

    Report

    Report Number
    2242352-2014-00256
    Event Type
    Malfunction
    Date Received
    March 14, 2014
    Date of Event
    February 18, 2014
    Report Date
    February 18, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. IT SHOWED SIGNS OF CLINICAL USAGE AND EVIDENCE OF BLOOD. A VISUAL INSPECTION DETERMINED THAT THE HEATING WIRE WAS DETACHED. ADDITIONAL EVALUATION IS REQUIRED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NON-CONFORMANCE REPORTED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO 2 OVERHEATED AND WOULD NOT TURN OFF. A REPLACEMENT DEVICE AND POWER SUPPLY WAS USED TO COMPLETE THE CASE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152838 VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-4000 25090520

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR