BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY PLUM SET WITH CONV PIN, SEC CAP PORT, 1 CL

    MDR report key: 528916 · Received February 25, 2004

    Report

    Report Number
    9615050-2004-00033
    Event Type
    Malfunction
    Date Received
    February 25, 2004
    Date of Event
    January 30, 2004
    Report Date
    January 30, 2004
    Manufacturer
    ABBOTT LABS
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED OF A TUBING SET CAUSING "CASSETTE ALARMS." IT WAS REPORTED THAT THE TUBING KEEPS GIVING CASSETTE ALARMS. THERE WAS NO REPORTED PT HARM OR DELAY IN CRITICAL THERAPY. MULTIPLE UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMARY PLUM SET WITH CONV PIN, SEC CAP PORT, 1 CL ADMINISTRATION SET FPA ABBOTT LABS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other