BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3941468 · Received April 16, 2014

    Report

    Report Number
    2016493-2014-00208
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 2, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: (B)(4) 2014; (B)(4). ALTHOUGH REQUESTED, THE AFFECTED DEVICES HAVE NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE AFFECTED DEVICES BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN OVER INFUSION: LASIX 250MG/125ML WAS PROGRAMMED AS A PRIMARY TO INFUSE AT 10 MG/HR (5 ML /HR) BUT THE ENTIRE BAG INFUSED BETWEEN 0100 AND 0400. THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTION. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT OR EVENT DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232213 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR ALARIS PC UNIT SN 4020123,| ALARIS PUMP MODULE ADMINISTRATION SET,| MODEL/LOT # UNK| THERAPY DATE