BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    MDR report key: 734868 · Received November 18, 2005

    Report

    Report Number
    6000001-2005-06811
    Event Type
    Malfunction
    Date Received
    November 18, 2005
    Date of Event
    October 1, 2005
    Report Date
    October 31, 2005
    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
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP IS IN THE PROCESS OF BEING EVALUATED. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FAILURE CODE 12:303:1984:0002 ON CHANNEL C. INFO WAS NOT PROVIDED REGARDING WHETHER OR NOT THE FAILURE OCCURRED DURING AN INFUSION. THE HOSP REP STATED THEY HAVE NO RECORD OF ANY PT INCIDENT INVOLVING THE PUMP SINCE THE LAST BAXTER SERVICE EVENT AND NO PT INJURY HAD BEEN REPORTED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED REGARDING PT'S DEMOGRAPHICS, MEDICATION INVOLVED, OR DEVICE PROGRAMMING. NO ADD'L CONTACT INFO 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. COLLEAGUE 3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN