BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    MDR report key: 1241364 · Received November 25, 2008

    Report

    Report Number
    6000001-2007-05206
    Event Type
    Malfunction
    Date Received
    November 25, 2008
    Date of Event
    January 1, 2007
    Report Date
    January 16, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    6000001-7/20/05-015-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY REPORTED AN INFUSION PUMP WITH A FAILURE CODE 12:303:984 CONDITION DURING PATIENT USE. EVALUATION SUMMARY: DURING PRODUCT EVALUATION, AN OUTDATED UIM (USER INTERFACE MODULE) SOFTWARE WAS OBSERVED. FAILURE CODE 12:303:984 IS MANIFESTED AS A RESULT OF THE UIM SOFTWARE BEEN OUTDATED. THE SOFTWARE WAS REPLACED. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE. THIS ISSUE IS BEING INVESTIGATED UNDER CAPA.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED FOR SERVICE. DURING TESTING, THE BAXTER TECHNICIAN REPORTED AN INFUSION PUMP WITH AN OUTDATED UIM (USER INTERFACE MODULE) SOFTWARE. THE EVENT WAS REPORTED TO HAVE OCCURRED DURING PATIENT USED. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION OR CONTACT WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3 VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1