BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLEY PCU

    MDR report key: 477368 · Received August 7, 2003

    Report

    Report Number
    2016493-2003-00039
    Event Type
    Malfunction
    Date Received
    August 7, 2003
    Report Date
    August 6, 2003
    Manufacturer
    ALARIS MEDICAL SYSTEMS
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NURSE REPORTED A BLEOMYCIN INFUSION WAS SET TO INFUSE AT 45CC/HR WITH 1000 CC BAG HUNG. NURSE FOUND APPROX 500 CC INFUSED IN 2 HRS. MD DISCONTINUED INFUSION. NO REPORT OF PT COMPROMISE OR MEDICAL INTERVENTION REQUIRED. NURSE STOPPED INFUSION BY TURNING DEVICE OFF AND ROLLING OFF ROLLER CLAMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDLEY PCU INFUSION DEVICE FRN ALARIS MEDICAL SYSTEMS 8100A *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN