BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2981156 · Received February 5, 2013

    Report

    Report Number
    9616066-2013-00083
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Report Date
    December 19, 2012
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN REC'D. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A NURSE IN THE EMERGENCY DEPARTMENT REPORTED THE CONNECTOR LOOSENED AFTER THE IV WAS STARTED. THERE WAS NO REPORT OF THE TUBING LEAKING. THERE WAS NOT REPORT OF PT HARM OR MEDICAL INTERVENTION REQUIRED. ALTHOUGH REQUESTED, NO ADD'L EVENT OR PT INFO PROVIDED BY THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47426 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION C24111E 12015323

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE| ALARIS PC UNIT