BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODLE

    MDR report key: 3941465 · Received April 16, 2014

    Report

    Report Number
    2016493-2014-00194
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    March 2, 2014
    Report Date
    March 19, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: (B)(4) 2014. (B)(4). DEVICES NOT RECEIVED, LOG REVIEW ONLY. THE CUSTOMER HAS REQUESTED AN EVENT LOG REVIEW. THE EVENT LOGS AND DATA SET 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 A CARDIZEM DRIP WAS INFUSING AT 15MG/HR. THE NURSE WENT OUT OF THE ROOM AND WHEN SHE CAME BACK IN THE PUMP WAS OFF. UPON QUESTIONING THE OTHER STAFF NO ONE REPORTED THEY TURNED THE DEVICE OFF. 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
    232212 ALARIS PUMP MODLE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE ADMIN SET: MODEL/LOT UNK| ALARIS PC UNIT: SN (B)(4)| ALARIS PUMP MODULE: (2) SN'S UNK