BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLEY PCU

    MDR report key: 521898 · Received February 6, 2004

    Report

    Report Number
    2016493-2004-00003
    Event Type
    Malfunction
    Date Received
    February 6, 2004
    Date of Event
    December 30, 2003
    Report Date
    January 8, 2004
    Manufacturer
    ALARIS MEDICAL SYSTEMS, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MEDLEY PCU AND 3 CHANNELS SHUT DOWN WITHOUT ALARMING DURING AN INFUSION. PT WAS IN ICU AND TUBING WAS ABLE TO BE PUT ON OTHER PUMP MODULES. THERE WAS NO REPORT OF PT COMPROMISE. MEDICATIONS RUNNING WERE TPN, LIPIDS AND HEPARIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDLEY PCU INFUSION DEVICE FRN ALARIS MEDICAL SYSTEMS, INC. 8000A *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening