BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP UK

    MDR report key: 1122143 · Received August 14, 2008

    Report

    Report Number
    6000001-2008-00464
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 7, 2008
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY THE REPAIR CENTER; HOWEVER, THE EVALUATION HAS NOT BEEN COMPLETED. A FOLLOW-UP MEDWATCH WILL BE COMPLETED UPON RECEIPT OF THE EVALUATION.

    Description of Event or Problem · 1

    WHILE CONNECTED TO A PATIENT THE UNIT GAVE THE FOLLOWING ERROR, FAILURE 302:435:118:0005. THE USER WAS UNABLE TO TAKE OUT THE ADMINISTRATION SET. THE REPORTER RELEASED THE ADMINISTRATION SET BY USING THE MANUAL TUBE RELEASE KNOB. NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. CONFIRMED BY THE CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1