BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2141394 · Received June 15, 2011

    Report

    Report Number
    9616066-2011-00259
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    April 22, 2011
    Report Date
    May 17, 2011
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: (B)(4) 2011. (B)(4). THE DEVICE HAS BEEN RECEIVED BUT THE FAILURE INVESTIGATION HAS NOT YET BEGUN. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE PRODUCT HAS BEEN EVALUATED.

    Description of Event or Problem · 1

    CUSTOMER'S MEDWATCH REPORTED A LEAK IN THE IV SET. REPORTED "RN WALKED INTO ROOM, ALARIS PUMP BEEPING, FLUID LEAKING, RN NOTED FLUID SQUIRTING FROM IV TUBING JUST UNDER PLASTIC PIECE THAT COMES FROM THE PUMP. RN CHANGED IV BAG AND TUBING." NO PT HARM REPORTED. NO ADDITIONAL EVENT INFO OR DESCRIPTION PROVIDED BY THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP 2420-0007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR ALARIS PC UNIT, SN UNK| ALARIS PUMP MODULE, SN UNK