BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMICUS SEPARATOR SYSTEM

    MDR report key: 1907551 · Received November 16, 2010

    Report

    Report Number
    3004548776-2010-00009
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    January 13, 2010
    Report Date
    January 13, 2010
    Manufacturer
    FENWAL INC.
    Product Code
    GKT
    PMA / PMN Number
    BK960005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE OPERATORS MANUAL INDICATES A WARNING AND A CAUTION REGARDING THE PRIMING OF THE KIT. WARNING: OPENING THE RETURN LINE ROLLER CLAMP AFTER VENIPUNCTURE AND BEFORE THE BLOOD SAMPLING POUCH IS FILLED MAY RESULT IN AN AIR EMBOLISM. CAUTION: THE KIT SHOULD BE ALMOST COMPLETELY FULL OF FLUID (SALINE AND ACD) AT THE END OF PRIME. THE CONTAINERS ON THE FRONT SCALE HOOKS SHOULD HAVE LITTLE OR NO FLUID IN THEM EXCEPT FOR THE CONTAINER ON THE FRONT LEFT SCALE HOOK ON A DOUBLE NEEDLE OR MNC KIT, OR THE CONTAINER ON THE FRONT RIGHT SCALE HOOK ON A SINGLE NEEDLE KIT. SOME AIR SHOULD BE EXPECTED NEAR THE FISTULA (S). IF THERE ARE LARGE AMOUNTS OF AIR IN THE KIT IMMEDIATELY FOLLOWING PRIME, DO NOT BEGIN COLLECTION. REMOVE THE KIT AND TRY INSTALLING AND PRIMING ANOTHER KIT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT WHILE SETTING UP FOR AN AMICUS PROCEDURE, THEY PERFORMED A RETURN LINE VENIPUNCTURE WITHOUT PRIMING THE RETURN LINE. THE ROLLER CLAMP WAS THEN OPENED AND THE DONOR RECEIVED THE TUBING FULL OF AIR. THE OPERATOR OF THE DEVICE CONTACTED FENWAL INQUIRING IF IT WAS OK TO DO ANOTHER PROCEDURE. THE FENWAL REPRESENTATIVE INDICATED THEY SHOULD IMMEDIATELY NOTIFY THEIR MEDICAL DIRECTOR OF THE EVENT. THE OPERATOR ALSO WANTED TO KNOW APPROXIMATELY HOW MANY MLS OF AIR IS IN THE TUBING. A FOLLOW UP CALL TO THE CUSTOMER WAS MADE AND THE CUSTOMER INDICATED THAT THEY HAD CALLED AN AMBULANCE BECAUSE THE DONOR WAS COUGHING AND THE MEDICAL DIRECTOR HAD COME TO EVALUATE THE DONOR. FENWAL INFORMED THE CUSTOMER THAT THERE IS APPROXIMATELY .2MLS IN EACH INCH OF TUBING. SEVERAL ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL DETAILS AND THE FACILITY WOULD NOT PROVIDE ANY DETAILS ON THE DONOR OR THE DONOR'S CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMICUS SEPARATOR SYSTEM AUTOMATED BLOOD CELL SEPARATOR GKT FENWAL INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention AMICUS KIT: CODE AND LOT# NOT PROVIDED