BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVALON ELITE

    MDR report key: 1822464 · Received August 26, 2010

    Report

    Report Number
    2032228-2010-00006
    Event Type
    Injury
    Date Received
    August 26, 2010
    Date of Event
    July 4, 2010
    Report Date
    August 24, 2010
    Manufacturer
    AVALON LABORATORIES LLC
    Product Code
    DWF
    PMA / PMN Number
    081820
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD AND INSPECTION DOCUMENT (LOTS 2130198, 2130215 AND 2130213) RELATED TO THE PRODUCT USED WAS REVIEWED AND FOUND NO NON CONFORMITIES. THE 13FR BI-CAVAL LUMEN CATHETER IS INSPECTED 100% IN PRODUCTION. THE IFU WARNS THAT INCORRECT INSERTION CAN CAUSE DAMAGE TO THE VESSELS AND/OR HEART STRUCTURES.

    Description of Event or Problem · 1

    PT POST BONE MARROW TRANSPLANT FOR HURLER'S SYNDROME DEVELOPED RSV PNEUMONITIS. REFERRED FOR ECMO. HICKMAN LINE PRESENT IN FEMORAL VEIN. CANNULATION PERFORMED WITH THE AID OF FLUOROSCOPIC GUIDANCE. DESPITE TRYING DIFFERENT GUIDEWIRES A WIRE COULD NOT BE PLACED INTO THE IVC. THE CANNULA WAS INSERTED AND THE TIP WAS DELIBERATELY LEFT IN THE RIGHT ATRIUM. ECMO WAS COMMENCED AND THE CANNULA WAS FUNCTIONING AS EXPECTED. AFTER 144 HOURS IT WAS DECIDED TO TURN HIM PRONE TO TRY AND AID LUNG RE-EXPANSION. ON TURNING PRONE HE WAS AWAKE AND A BOLUS OF SEDATION WAS ADMINISTERED. HIS HEART RATE FELL AND HE HAD A SHORT PERIOD OF CPR BEFORE REGAINING HIS OUTPUT. HE REMAINED STABLE FOR ABOUT 10 MINUTES BEFORE AGAIN HIS HEART RATE BEGAN TO FALL WITH A FALLING BLOOD PRESSURE. AN URGENT ECHO WAS PERFORMED THAT REVEALED A PERICARDIAL EFFUSION. "REMEDIAL ACTION TAKEN AND BY WHOM UPON THE OCCURRENCE OF THE EVENT. HIS CHEST WAS OPENED AND FRESH BLOOD WAS DRAINED FROM THE PERICARDIUM. ON OPENING THE PERICARDIUM THE CARDIAC OUTPUT RETURNED. THE CANNULA APPEARED TO BE RELATIVELY HIGH IN THE ATRIUM AND WAS LEFT IN POSITION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVALON ELITE 19 FR BI-CAVAL LUMEN CATHETER DWF AVALON LABORATORIES LLC 19 FR AVALON ELITE 081250616474

    Patients

    Seq Age Sex Outcome Treatment
    1 386 DA Hospitalization