BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3941488 · Received April 16, 2014

    Report

    Report Number
    9616066-2014-00390
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    March 29, 2014
    Report Date
    April 1, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED LEAK BECAUSE THE SET HAS BEEN DISCARDED BY THE CUSTOMER AND WILL NOT BE RETURNED. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE MALE LUER DISCONNECTED FROM THE LUER LOCKING CANNULA FEMALE LUER DURING A HEPARIN INFUSION. THE PATIENT'S DAD MOVED THE PATIENT UP IN THE BED AND NOTICED THE SET WAS DISCONNECTED FROM THE PICC. THE PICC WAS CLAMPED AND THE LUER LOCKING CANNULA WAS REMOVED. THERE WAS NO BLOOD BACKFLOW SO THE RN WITHDREW AIR UNTIL THERE WAS BLOOD RETURN AND THEN FLUSHED THE PICC WITH NORMAL SALINE. A NEW HEPARIN BAG AND IV SET WERE HUNG AND THE INFUSION CONTINUED. EVENT OCCURRED IN THE PEDIATRIC UNIT .THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTION. NO FURTHER PATIENT/EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232615 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 2123-0007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK VERSASAFE SPLIT SEPTUM PLASTIC CANNULA: LOT UNK,| PICC LINE: MFG/MODEL LOT UNK| MODEL 9391-0200