BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1232094 · Received November 7, 2008

    Report

    Report Number
    6000001-2008-00727
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 7, 2008
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE REPORTED CONDITION OF "WILL NOT LOAD TUBING" WAS CONFIRMED DURING PRODUCT EVALUATION. INSPECTION OF THIS PUMP REVEALED THE CONDITION WAS CAUSED BY AN INOPERATIVE OPEN KEY DUE TO AN INTERMITTENT PUMP HEAD MODULE KEYPAD. THE PUMP WAS NOT REPAIRED AT THIS TIME BECAUSE IT IS A STAY-IN DEVICE OWNED BY BAXTER. THE PUMP IS IN BAXTER'S INVENTORY AND ALL REPAIRS WILL BE PERFORMED AT A LATER DATE. THIS ISSUE IS CURRENTLY BEING INVESTIGATED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A DEVICE THAT WILL NOT LOAD A SET. IT IS UNK WHEN THIS CONDITION OCCURRED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REPRESENTATIVE. NO ADD'L INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CX VOLUMETRIC INFUSION PUMP 80FRN FRN BAXTER HEALTHCARE PTE. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1