BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 2210396 · Received August 8, 2011

    Report

    Report Number
    2242352-2011-01078
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 20, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY BEING INVESTIGATED AND THE RESULTS ARE BEING EVALUATED AND ANALYZED WITH SIMILAR EVENTS. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE DEVICE EVAL US COMPLETE. ITEMS MARKED "NI" ARE UNK TO US AT THIS TIME. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO 2 DEVICE WAS INTERMITTENTLY WORKING. THE HARVESTER WAS APPROX 25% COMPLETED WITH BRANCH LIGATION WHEN SHE EXPERIENCED A SHUT DOWN. SHE WAITED THE RECOMMENDED 30 SECONDS (BY CLOCK) AND RESUMED HARVESTING. HER COMPLAINT IS THAT THE DEVICE REPEATEDLY SHUT DOWN EARLIER THAN 14 SECONDS OF OPERATION. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT EFFECTS. THE POWER SUPPLY SETTING WAS T 3 AND THE DEVICE WAS PRE-TESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC. VH-4000 0300001558

    Patients

    Seq Age Sex Outcome Treatment
    1 NI