BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 1339573 · Received January 7, 2009

    Report

    Report Number
    9616066-2009-00004
    Event Type
    Malfunction
    Date Received
    January 7, 2009
    Date of Event
    December 2, 2008
    Report Date
    December 9, 2008
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FPA
    PMA / PMN Number
    K022209
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED A LEAK IN THE PUMPING SEGMENT OF THE IV ADMINISTRATION SET DURING A CHEMOTHERAPY INFUSION. NO PATIENT OR STAFF HARM REPORTED AND NO OTHER EVENT DETAILS AVAILABLE. THE IV ADMINISTRATION SET WAS RECEIVED. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CARDINAL HEALTH ALARIS PRODUCTS 10015861 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK