BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 502553 · Received December 5, 2003

    Report

    Report Number
    6000001-2003-09383
    Event Type
    Malfunction
    Date Received
    December 5, 2003
    Date of Event
    November 1, 2003
    Report Date
    November 26, 2003
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTED A FAIL CODE 810:011, WHICH OCCURRED DURING PATIENT INFUSION. ALTHOUGH ATTEMPTS WERE MADE BY BAXTER, DETAILS WERE NOT AVAILABLE REGARDING ADDITIONAL CONTACT INFORMATION, PATIENT DEMOGRAPHICS, MEDICATION INVOLVED, OR PUMP PROGRAMMING. THE HOSPITAL REPRESENTATIVE STATED THAT THERE HAVE BEEN NO REPORTS OF ANY PATIENT INCIDENT INVOLVING THIS 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 UNKNOWN