BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE IV ADMINISTRATION SET

    MDR report key: 3023140 · Received February 27, 2013

    Report

    Report Number
    9616066-2013-00118
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 4, 2013
    Report Date
    February 25, 2013
    Manufacturer
    CAREFUSION CORPORATION
    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). THE REPORT OF A SET LEAKING COULD NOT BE CONFIRMED BECAUSE THE SET WAS DISCARDED BY THE CUSTOMER. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SET LEAKED DURING AN ETOPOSIDE INFUSION. CUSTOMER STATED THE LEAK WAS AT THE CONNECTION OF THE BURETTE TO THE DRIP CHAMBER. NO PT HARM OR MEDICAL INTERVENTION REPORTED. CUSTOMER STATED THAT NO FURTHER PT OR EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85019 ALARIS PUMP MODULE IV ADMINISTRATION SET FPA CAREFUSION CORPORATION 10012293 12075624

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK