BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 3140136 · Received May 29, 2013

    Report

    Report Number
    2242352-2013-00509
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 4, 2013
    Report Date
    May 8, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. IT SHOWED NO SIGNS OF CLINICAL USAGE OR EVIDENCE OF BLOOD. A VISUAL INSPECTION DETERMINED THAT THE C-RING WAS SPLIT IN TWO. 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. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE C-RING BROKE ON THE HEMOPRO DEVICE. NOTHING FELL INTO THE PATIENT AND NO INTERVENTION WAS REQUIRED. A REPLACEMENT DEVICE WAS USED TO COMPLETED THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235003 VASO VIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH - 3000 25074131

    Patients

    Seq Age Sex Outcome Treatment
    1 NA