BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    MDR report key: 1963598 · Received January 19, 2011

    Report

    Report Number
    6000001-2011-00332
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. TE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH CAPA (CORRECTIVE AND PREVENTIVE ACTION) (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION WAS CONFIRMED BUT NOT DUPLICATED. THE ASSIGNABLE CAUSE IS A DEFECTIVE SPEAKER HARNESS. THE SPEAKER HARNESS HAS BEEN REPLACED. ADDITIONAL: A SERVICE HISTORY REVIEW HAS BEEN PERFORMED AND THE DEVICE HAS NOT BEEN PREVIOUSLY SERVICED FOR THE REPORTED CONDITION.

    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.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WITH FAILURE (B)(4). THE EVENT OCCURRED "UPON POWER UP" IN THE BIOMED SERVICE DEPARTMENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. DURING SERVICE AT BAXTER, IT WAS DISCOVERED THAT THE DEVICE AUDIBLY FAILED TO ALARM. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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