BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVALON ELITE

    MDR report key: 1822135 · Received August 26, 2010

    Report

    Report Number
    2032228-2010-00003
    Event Type
    Death
    Date Received
    August 26, 2010
    Date of Event
    June 1, 2009
    Report Date
    August 26, 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

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED LOT NUMBER DOES NOT BELONG TO AVALON LABS. SINCE AVALON LABS MFR 13FR BI-CAVAL LUMEN CATHETER SIMILAR TO REPORTED COMPLAINT, DHR AND INSPECTION DOCUMENT WERE REVIEWED, (LOTS 2130198, 2130199, 2131955, 2131610, 2131609 AND 2131608) FOUND NO NON CONFORMITIES.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS RECEIVED ON 07/29/2010 ON A PHONE CONFERENCE CALL WITH (B)(4) OFFICE, AND WAS SUBMITTED IN WRITING ON 08/05/2010 BY THE (B)(6) AS IS QUOTED AS FOLLOWS: BRIEF DESCRIPTION. PT WAS A MECONIUM ASPIRATION. NO DIFFICULTY ENCOUNTERED AT CANNULATION. CANNULA INSERTED INTO THE IVC WITH ECHO GUIDANCE. NO EVIDENCE OF PERICARDIAL FLUID IMMEDIATELY AFTER CANNULATION. POST CANNULATION ACTIVATED CLOTTING TIMES WERE VERY HIGH (APPROX 1000 SEC) AND IT TOOK 24 HOURS FOR CLOTTING TO RETURN TO WITHIN PARAMETER (140-160 SEC). ECMO RUN PROGRESSED WELL WITH NO FURTHER COMPLICATION. THERE WAS THEN A SUDDEN DROP IN BLOOD PRESSURE AFTER 79 HOURS OF ECMO SUPPORT THAT DID NOT RESPOND TO A FLUID BOLUS. RHYTHM THEN CHANGED TO "?" VF WITH 2 DC CARDIOVERSION ATTEMPTED. SINUS RHYTHM WAS RE-ESTABLISHED, BUT BLOOD PRESSURE REMAINED LOW AND CHEST COMPRESSIONS WERE CONTINUED. URGENT ECHO CONFIRMED A LARGE PERICARDIAL COLLECTION. ATTEMPT WAS MADE AT NEEDLE ASPIRATION WHILST SURGEONS WERE CONTACTED. REMEDIAL ACTION TAKEN AND BY WHOM UPON THE OCCURRENCE OF THE EVENT. EMERGENCY MEDIAN STERNOTOMY WAS PERFORMED. THE PERICARDIAL CAVITY WAS FILLED WITH BLOOD. THIS WAS FRESH BLOOD WITHOUT ANY CLOT. TWO SMALL HOLES WERE IDENTIFIED IN THE RIGHT ATRIUM AT JUNCTION INFERIOR VENA CAVA.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DA Death