BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3941469 · Received April 16, 2014

    Report

    Report Number
    2016493-2014-00205
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    February 25, 2014
    Report Date
    April 1, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: 04/16/2014. INTERNAL FILE NO: (B)(4). DEVICES NOT RECEIVED, LOG REVIEW ONLY. THE CUSTOMER HAS REQUESTED AN EVENT LOG REVIEW. THE EVENT LOGS 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

    LASIX WAS ORDERED TO INFUSE AT 20MG/HR, BUT IT WAS FOUND INFUSION AT 20ML/HR. THE LASIX WAS 10MG/ML AND THE INFUSION SHOULD HAVE BEEN AT 2ML/HR. AT 2250, THE INFUSION WAS CHANGED TO THE INTENDED RATE OF 2ML/HR AND THEN THE INFUSION WAS STOPPED AT 2300. THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTION. NO FURTHER PATIENT/EVENT INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232621 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

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