BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2 WITH VASOSHIELD

    MDR report key: 3941717 · Received March 5, 2014

    Report

    Report Number
    2242352-2014-00213
    Event Type
    Malfunction
    Date Received
    March 5, 2014
    Date of Event
    February 7, 2014
    Report Date
    February 7, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. IT SHOWED SIGNS OF CLINICAL USAGE AND NO EVIDENCE OF BLOOD. A VISUAL INSPECTION DID NOT IDENTIFY ANY NON-CONFORMITIES. THE BTT BALLOON WAS INFLATED WITH 25 CC OF AIR THROUGH THE BALLOON INFLATION PORT AND SUBMERGED IN WATER; NO LEAK WAS OBSERVED. THE CO2 INSUFFLATION PORT WAS TESTED; AIR WOULD NOT FLOW THROUGH. ADHESIVE WAS OBSERVED IN THE INSUFFLATION OPENING ON THE BODY. BASED UPON THE EVALUATION RESULTS, THE REPORTED COMPLAINT WAS CONFIRMED. ADDITIONAL TESTING REQUIRED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED. 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 DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, IT WAS NOTICED THAT THE BTT PORT WAS OCCLUDED. HOWEVER, AFTER LOOKING AT THE PORT LATER, THEY WERE ABLE TO CLEAR THE OBSTRUCTION BY READJUSTING THE BLUE VALVE INSIDE THE CO2 CONNECTION SITE. IT WAS NOT BEING COMPRESSED PRIOR TO TURNING IT SLIGHTLY. 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
    131644 VASOVIEW HEMOPRO 2 WITH VASOSHIELD ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-4001 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI