BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 4230960 · Received October 15, 2014

    Report

    Report Number
    9616066-2014-01013
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Report Date
    September 23, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED COMPLAINT BECAUSE THE SET HAS BEEN DISCARDED BY THE CUSTOMER AND WILL NOT BE RETURNED. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE TIP OF THE MALE LUER ON THE CAREFUSION SET BROKE OFF IN THE FEMALE LUER OF THE B.BRAUN EXTENSION SET. THERE WAS NO REPORT OF PATENT HARM OR MEDICAL INTERVENTION. NO ADDITIONAL PATIENT OR EVENT DETAILS WERE PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652813 ALARIS PUMP MODULE ADMINISTRATION SET IV INFUSION SET FPA CAREFUSION CORPORATION 2420-0007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK BBRAUN EXTENSION SET: MODEL #470100, LOT# UNK