BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 2073135 · Received April 29, 2011

    Report

    Report Number
    6000001-2011-03299
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 11, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4). THE DEVICE HAS NOT BEEN PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION OF "FAILURE CODE 550:320:844:0000 FAILED TO AUDIBLY ALARM."

    Additional Manufacturer Narrative · 1

    THE CONDITION OF FAILED TO AUDIBLY ALARM WAS CONFIRMED THROUGH EVALUATION AND WAS FOUND TO BE DUE TO A DISCONNECTED REAR HARNESS CONNECTOR. THE REAR HARNESS CONNECTOR WAS RECONNECTED TO CORRECT THE CONDITION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    DURING DEVICE EVALUATION BY BAXTER ON A COLLEAGUE INFUSION PUMP FAILURE CODE 550:320:844:0000 FAILED TO AUDIBLY ALARM. THERE WAS NO PATIENT INVOLVEMENT, INJURY, OR MEDICAL INTERVENTION ASSOCIATED WITH THIS DEVICE. THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 5.04.00 CATEGORIZED AS UNREMEDIATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1