BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1160402 · Received September 16, 2008

    Report

    Report Number
    6000001-2007-01620
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    December 1, 2006
    Report Date
    December 21, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE PUMP BE RECEIVED FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPORTED AN INFUSION PUMP WITH A FAILURE CODE 403. THE INCIDENT HAPPENED PRIOR TO USE ON THE PATIENT HENCE THERE WAS NO REPORTED PATIENT/USER INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS KNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1