BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 1339579 · Received January 7, 2009

    Report

    Report Number
    9616066-2009-00008
    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

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: 01/07/2009.

    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 REQUESTED, BUT HAS BEEN DISCARDED BY THE CUSTOMER.

    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