BEUDAMED
    FDA Adverse Event Other Summary report: N

    LAMICUS SEPARATOR SYSTEM

    MDR report key: 2093992 · Received April 26, 2011

    Report

    Report Number
    3004548776-2011-00001
    Event Type
    Other
    Date Received
    April 26, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    FENWAL, INC.
    Product Code
    GKT
    PMA / PMN Number
    BK960005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED WHILE SETTING UP A DOUBLE NEEDLE AMICUS PROCEDURE THE RETURN LINE WAS NOT PRIMED BY THE OPERATOR PRIOR TO VENIPUNCTURE AND APPROXIMATELY 1.2 ML OF AIR WAS INFUSED. DONOR DID NOT EXPERIENCE ANY SYMPTOMS OF AIR EMBOLISM. THE PROCEDURE WAS DISCONTINUED IMMEDIATELY. THE FACILITIES MEDICAL DIRECTOR WAS INFORMED OF THE SITUATION AND DONOR FOLLOW UP WAS RECOMMENDED. DONOR CONDITION WAS STABLE AND LEFT ON OWN ACCORD. THE CENTER FOLLOWED UP WITH THE DONOR AT A LATER DATE AND THERE WERE NO ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMICUS SEPARATOR SYSTEM AUTOMATED BLOOD CELL SEPARATOR GKT FENWAL, INC. NA FA11A17173

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other LOT FA11A17173| AMICUS APHERESIS KIT DOUBLE NEEDLE: (B)(4)