BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVALON ELITE

    MDR report key: 1822136 · Received August 26, 2010

    Report

    Report Number
    2032228-2010-00004
    Event Type
    Death
    Date Received
    August 26, 2010
    Date of Event
    July 25, 2009
    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, 2130199, 2131955, 2131610, 2131609) RELATED TO THE PRODUCT USED WAS REVIEWED AND FOUND NO NON CONFORMITIES. THE 13FR BI-CAVAL LUMEN CATHETER IS INSPECTED 100% IN PRODUCTION.

    Description of Event or Problem · 1

    CONGENITAL DIAPHRAGMATIC HERNIA (CDH) PT, CANNULATED FOR VV ECMO BY MR (B)(6). CANNULATION PERFORMED WITH ECHOCARDIOGRAPHIC GUIDANCE. SOME DIFFICULTY WAS ENCOUNTERED IN PLACING GUIDEWIRE AND SUBSEQUENT CANNULA INTO THE IVC AND THIS WAS PRESUMED TO BE SECONDARY TO THE DISTORTED ANATOMY CAUSED BY THE CDH. IMMEDIATELY FOLLOWING CANNULATION, THERE HAD BEEN A DIP IN BLOOD PRESSURE REQUIRING BOLUSES OF BLOOD, HAS, ADRENALINE AND CALCIUM. THE PT'S CONDITION IMPROVED AND HE REMAINED STABLE WITH NO EVIDENCE OF PERICARDIAL EFFUSION. AT 36 HOURS POST CANNULATION, THERE WAS A LOSS OF FLOW WITHIN THE ECMO CIRCUIT AND A CONCOMITANT DIP IN OXYGEN SATURATIONS. THE PT WAS GIVEN A BOLUS OF FLUID AND IMPROVED TRANSIENTLY BEFORE LOOSING HIS CARDIAC OUTPUT. CPR WAS COMMENCED AND A URGENT ECHOCARDIOGRAM PERFORMED. THE ECHO REVEALED A LARGE PERICARDIAL COLLECTION. REMEDIAL ACTION TAKEN AND BY WHOM UPON THE OCCURRENCE OF THE EVENT. IMMEDIATELY ON DIAGNOSING THE PERICARDIAL COLLECTION, THE CHEST WAS OPENED VIA A MEDIAN STERNOTOMY. FRESH LOOKING BLOOD WAS DRAINED FROM THE PERICARDIAL CAVITY AND A SMALL HOLE WAS IDENTIFIED IN THE RIGHT ATRIUM ANTERIOR TO THE ENTRANCE OF THE IVC. ON RELIEVING THE TAMPONADE, THE CARDIAC FUNCTION IMPROVED, NORMAL BLOOD PRESSURE WAS ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVALON ELITE 13 FR BI-CAVAL LUMEN CATHETER DWF AVALON LABORATORIES LLC 13 FR AVALON ELITE 0810250216470

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA Death