BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2 WITH VASOSHIELD

    MDR report key: 3770392 · Received January 24, 2014

    Report

    Report Number
    2242352-2014-00016
    Event Type
    Malfunction
    Date Received
    January 24, 2014
    Date of Event
    January 2, 2014
    Report Date
    January 3, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    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 C-RING WAS SPLIT IN HALF. THE C-RING ASSEMBLY WAS INSPECTED UNDER A MICROSCOPE; THE C-RING DISPLAYED SIGNS OF EXPOSURE TO HEAT AT THE FRACTURE SITE. THIS TYPE OF FAILURE IS CONSISTENT WITH THE APPLICATION OF HEAT FROM THE HEMOPRO TOOL WHILE IN CLOSE PROXIMITY WITH THE C-RING ASSEMBLY. BASED UPON THE EVALUATION RESULTS, THE REPORTED COMPLAINT WAS CONFIRMED FOR C-RING FRACTURE DUE TO HEAT EXPOSURE. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NON-CONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT TOWARDS THE END OF AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE C-RING BROKE IN HALF ON THE VASOVIEW HEMOPRO 2 WITH VASOSHIELD. THE SECOND PIECE WAS RETRIEVED FRO THE LONG PLASTIC SLEEVE. NOTHING FELL INTO THE PATIENT. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57351 VASOVIEW HEMOPRO 2 WITH VASOSHIELD ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-4001 25089396

    Patients

    Seq Age Sex Outcome Treatment
    1 NI