BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 700432 · Received February 23, 2006

    Report

    Report Number
    6000001-2006-02870
    Event Type
    Malfunction
    Date Received
    February 23, 2006
    Date of Event
    February 7, 2006
    Report Date
    February 7, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    6000001-2/25/05-004-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING SERVICE THE DEVICE HAD FAILURE CODE 570:320:844:000. THE HOSPITAL REPRESENTATIVE STATED THEY HAVE NO RECORD OF ANY PATIENT INCIDENT INVOLVING THE PUMP SINCE THE LAST BAXTER SERVICE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA