BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1172756 · Received September 22, 2008

    Report

    Report Number
    6000001-2008-00554
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Date of Event
    September 14, 2008
    Report Date
    September 17, 2008
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FRN
    PMA / PMN Number
    K010566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A 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 REPRESENTATIVE REPORTED AN INFUSION PUMP WITH CHANNEL A OPEN BUTTON THAT GIVES NO RESPONSE. INFORMATION WAS NOT PROVIDED REGARDING WHETHER OR NOT THE FAILURE OCCURRED DURING PATIENT INFUSION. THE HOSPITAL REPRESENTATIVE STATED THAT THERE WERE NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP 80FRN FRN BAXTER HEALTHCARE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1