BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CXE1 PUMP UNREFURB

    MDR report key: 1920371 · Received December 10, 2010

    Report

    Report Number
    6000001-2010-05725
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 15, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE CONDITION OF FAILURE TO ALARM WAS CONFIRMED DUE TO A DISCONNECTION BETWEEN THE INVERTER HARNESS AND THE MAIN SPEAKER HARNESS. THE INVERTER HARNESS WAS RECONNECTED TO THE MAIN SPEAKER HARNESS TO CORRECT THE REPORTED CONDITION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4)

    Additional Manufacturer Narrative · 1

    BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH MDQ-CAPA-(B)(4). THE DEVICE HAS NOT BEEN PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION OF FAILURE CODE OF 550:320:654:0000 (B)(4).

    Description of Event or Problem · 1

    THE BAXTER TECHNICIAN REPORTED A COLLEAGUE PUMP THAT HAS A FAILURE CODE OF 550:320:654:0000 THAT HAD NO AUDIBLE ALARM. THE REPORTED CONDITION WAS IDENTIFIED DURING SERVICE. THERE WAS NO DOCUMENTED PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 6.13.90, WHICH IS CLASSIFIED AS REMEDIATED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CXE1 PUMP UNREFURB PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1