BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2 WITH VASOSHIELD

    MDR report key: 2201426 · Received August 3, 2011

    Report

    Report Number
    2242352-2011-01139
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 28, 2011
    Report Date
    July 28, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    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. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WERE NO NON CONFORMANCE ISSUES (S) WITH THIS PRODUCTION LOT. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HEMOPRO 2 TRIGGER GOT STUCK IN THE ON POSITION. THE HARVESTER HAD TO FORCE THE DEVICE BACK TO THE OFF POSITION BECAUSE IT FAILED TO RECOIL ON ITS OWN. THE REPORTER STATED "ONCE HE WAS FINISHED WITH THE CASE, HE REMOVED THE DEVICE FROM THE PT AND ACTIVATED THE DEVICE. WHILE THE DEVICE WAS ACTIVATED, HE REMOVED HIS HAND FROM THE TRIGGER AND INSTEAD OF THE TRIGGER RECOILING INTO THE OFF POSITION IT REMAINED ON". A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. MAQUET CARDIOVASCULAR ANTICIPATES RETURN OF THE PRODUCT IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO 2 WITH VASOSHIELD ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-4001 25027933

    Patients

    Seq Age Sex Outcome Treatment
    1 NA