BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 4080884 · Received August 26, 2014

    Report

    Report Number
    9616066-2014-00881
    Event Type
    Malfunction
    Date Received
    August 26, 2014
    Report Date
    July 31, 2014
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT WILL BE RETURNED PER CUSTOMER. THE CUSTOMER'S COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE PRODUCT WAS NOT DISCARDED AND NOT BE RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    VALUE ANALYSIS COORDINATOR REPORTED VAGUE COMPLAINT THAT "SET LEAKED." ER MANAGER REPORTED THAT SET WAS IN USE ON PT AT TIME OF EVENT. NO PT HARM OR MEDICAL INTERVENTION OCCURRED. NO FURTHER PT/EVENT INFO WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515714 ALARIS PUMP MODULE ADMINISTRATION SET IV INFUSION SET FPA CAREFUSION CORP. 2420-0500 14065123

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK BD 3ML SYRINGE, MODEL/LOT NUMBER UNK