BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIX INFUSION PUMP

    MDR report key: 719760 · Received July 26, 2005

    Report

    Report Number
    6000001-2005-03013
    Event Type
    Malfunction
    Date Received
    July 26, 2005
    Date of Event
    June 29, 2005
    Report Date
    June 29, 2005
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING SERVICE BY BAXTER TECH THE DEVICE FAILED ACCURACY TEST WITH UNDER DELIVERY. THE HOS PREP. STATED THEY HAVE NO RECORD OF ANY PT INVOLVING THE PUMP SINCE THE LAST BAXTER SERVICE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA