BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3222020 · Received July 3, 2013

    Report

    Report Number
    2016493-2013-00297
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE AFFECTED PRODUCT HAVE BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN IV FLUID OVER INFUSION. A NEW 1 LITER IV FLUID BAG WAS HUNG AT 0600 WITH A RATE OF 60 ML/HOUR AND THE BAG WAS FOUND EMPTY AT 0800. THERE WAS NO PT HARM OR MEDICAL INTERVENTION. NO FURTHER PATIENT/EVENT INFO WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304918 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE ADMINISTRATION SET:| ALARIS PC UNIT: SN (B)(4)| MODEL/LOT # UNK