BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET

    MDR report key: 317804 · Received February 22, 2001

    Report

    Report Number
    2016493-2001-00017
    Event Type
    Malfunction
    Date Received
    February 22, 2001
    Manufacturer
    ALARIS MEDICAL SYSTEMS
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS ALLEGED THAT DURING TESTING AT THE FACILITY THE IV SETS OVERINFUSED. NO DETAILS OR SPECIFICATIONS WERE GIVEN. THERE WAS NO PT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6961 ADMINISTRATION SET IV TUBING FPA ALARIS MEDICAL SYSTEMS 59793 C73062-1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA