BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    MDR report key: 1905706 · Received November 23, 2010

    Report

    Report Number
    6000001-2010-05183
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 2, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS STILL IN PROCESS OF BEING EVALUATED. UPON COMPLETION OF BAXTER?S INVESTIGATION A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE CAUSE WAS A FAULTY PUMPHEAD MODULE. THE PUMPHEAD MODULE HAS BEEN REPLACED. ADDITIONAL: A SERVICE HISTORY REVIEW REVEALED THAT THE DEVICE HAS NOT BEEN SERVICED BY BAXTER PRIOR TO THIS EVENT. A DEVICE HISTORY REVIEW WAS PERFORMED FINDING THREE EXCEPTIONS DURING MANUFACTURING, HOWEVER, THE DEVICE WAS RE-TESTED AND FOUND TO BE PERFORMING AS DESIGNED. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 5.04.00, CATEGORIZED AS UNREMEDIATED.

    Description of Event or Problem · 1

    DURING DEVICE EVALUATION BY BAXTER ON A COLLEAGUE CX VOLUMETRIC INFUSION PUMP, A CONSTANT UPSTREAM OCCLUSION ON CHANNEL C OCCURRED. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THIS DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SOFTWARE VERSION FOR THIS DEVICE IS CURRENTLY NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1