BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 1586275 · Received December 17, 2009

    Report

    Report Number
    9616066-2009-00641
    Event Type
    Malfunction
    Date Received
    December 17, 2009
    Date of Event
    October 15, 2009
    Report Date
    November 24, 2009
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THE SET WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. A F/U REPORT WILL BE SUBMITTED WITH ANY NEW RELEVANT INFO.

    Description of Event or Problem · 1

    CUSTOMER REPORTED MAGNESIUM IV WAS HUNG AS SECONDARY INFUSION. SECONDARY TUBING CLAMP WAS OPENED AND ENTIRE MEDICATION RAN INTO THE PRIMARY BAG. THE PT WAS NOT HARMED. FACILITY REPORTED PUMP IN USE WAS DETERMINED TO BE FULLY FUNCTIONAL AND NOT PART OF THE EVENT. ALTHOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    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 82 YR