BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1160279 · Received September 16, 2008

    Report

    Report Number
    6000001-2007-01160
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    December 1, 2006
    Report Date
    December 12, 2006
    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
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REQUESTED BY BAXTER QUALITY MANAGEMENT FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. SHOULD THE PUMP BE RECEIVED FOR EVALUATION, A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ADDITONAL INFORMATION BECOMES AVAILABLE. 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 FACILITY REPORTED AN INFUSION PUMP WITH A FAILURE CODE 703:00. INFORMATION WAS NOT PROVIDED REGARDING WHETHER OR NOT THE DEVICE WAS IN PATIENT USE WHEN THE EVENT OCCURRED. INFORMATION WAS NOT PROVIDED REGARDING WHETHER OR NOT THERE HAD BEEN ANY PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THE DEVICE. NO ADDITIONAL INFORMATION OR CONTACT WAS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1