BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2901378 · Received November 19, 2012

    Report

    Report Number
    9616066-2012-00862
    Event Type
    Malfunction
    Date Received
    November 19, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 25, 2012
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, THE SET HAS NOT BEEN RETURNED. SHOULD THE DEVICE BE RECEIVED, A F/U REPORT WILL BE SUBMITTED WITH THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    PER MEDWATCH REPORT, "IV TUBING DETACHED/BROKE OFF FROM DISTAL TIP". THERE WAS NO REPORT OF PT HARM OR MEDICAL INTERVENTION. NO FURTHER PT OR EVENT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP 2426-0007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR