BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVALON ELITE

    MDR report key: 1822463 · Received August 26, 2010

    Report

    Report Number
    2032228-2010-00005
    Event Type
    Injury
    Date Received
    August 26, 2010
    Date of Event
    June 24, 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 2131608, 2131609, 2131610, AND 2131955) RELATED TO THE PRODUCT USED WAS REVIEWED AND FOUND NO NON CONFORMITIES. THE 13FR BI-CAVAL LUMEN CATHETER ARE 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

    BRIEF DESCRIPTION: TETRALOGY OF FALLOT WITH PERSISTENT PULMONARY HYPERTENSION CANNULATED FOR VV ECMO BY (B)(6). CANNULA INSERTED WITH FLUOROSCOPIC GUIDANCE. NO IMMEDIATE COMPLICATION APPARENT. CANNULA APPEARED IN GOOD POSITION ON INITIAL CHEST X-RAY BUT SUBSEQUENTLY MOVED. ECHOCARDIOGRAPHY SHOWED CANNULA TIP TO BE WITHIN THE CORONARY SINUS AND WAS REPOSITIONED AND A TRIAL OFF COMMENCED AFTER 40 HOURS OF ECMO SUPPORT. AS IS OUR PRACTICE ON COMMENCING TRIAL OFF THE FLOW WAS INCREASED. THERE WAS THEN A CARDIAC ARREST AND REPEAT ECHO REVEALED A PERICARDIAL EFFUSION. REMEDIAL ACTION TAKEN AND BY WHOM UPON THE OCCURRENCE OF THE EVENT. THE CHEST WAS OPENED THROUGH A MEDIAN STERNOTOMY AND A HOLE IN THE RIGHT ATRIUM WAS IDENTIFIED JUST ANTERIOR TO THE ENTRANCE OF THE INFERIOR VENA CAVA. THIS WAS REPAIRED WITH A SINGLE PROLENE SUTURE AND AS THE PT WAS STABLE OFF ECMO THE CANNULA WAS REMOVED AND THE CHEST CLOSED. PT OUTCOME: THE PT REMAINED STABLE AND WAS DISCHARGED FROM THE HOSPITAL.

    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 090216017953

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA Life Threatening