BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 2210358 · Received August 9, 2011

    Report

    Report Number
    2242352-2011-01088
    Event Type
    Injury
    Date Received
    August 9, 2011
    Report Date
    July 22, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. WE WILL CONTINUE PURSUING THE DEVICE BEING RETURNED BY THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. ITEMS MARKED "NI" ARE UNKNOWN TO US AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE REPORTER STATES "THAT WHEN THE VASOVIEW HEMO PRO WAS PLUGGED INTO THE CORD, THE TIP STARTED TO GLOW AND THEN SPARKED AND BURST INTO FLAMES." A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. MAQUET CARDIOVASCULAR ANTICIPATES RETURN OF THE PRODUCT IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASO VIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-3000 0300001372

    Patients

    Seq Age Sex Outcome Treatment
    1 NI