BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1869731 · Received October 14, 2010

    Report

    Report Number
    6000001-2010-04043
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 20, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-3/15/05-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER AS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH MDQ-CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL: A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE WAS NOT PREVIOUSLY SERVICED FOR THE REPORTED CONDITION. DEVICE EVALUATION: THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE CAUSE WAS A FAULTY PHM (PUMPHEAD MODULE). THE PHM HAS BEEN REPLACED.

    Description of Event or Problem · 1

    DURING THE PRODUCT EVALUATION OF ANOTHER REPORT, A BAXTER SERVICE TECHNICIAN REPORTED FINDING A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 810:11 ON CHANNEL. FAILURE CODE 810:11 INTERRUPTED DELIVERY DURING THE DOWNSTREAM OCCLUSION TEST. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION FOR THIS DEVICE IS 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