BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1920823 · Received December 13, 2010

    Report

    Report Number
    6000001-2010-05764
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 19, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    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). DEVICE EVALUATION: THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE CAUSE IS A DEFECTIVE SPEAKER. THE MAIN SPEAKER ASSY HAS BEEN REPLACED. ADDITIONAL: THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 5.03.00, CATEGORIZED AS UNREMEDIATED. 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). A TREND REVIEW HAS BEEN PERFORMED AND THERE HAVE BEEN SIMILAR REPORTS MADE TO BAXTER. THE ROOT CAUSE WILL CONTINUE TO BE INVESTIGATED THROUGH CAPA (CORRECTIVE AND PREVENTIVE ACTION) INVESTIGATION (B)(4).

    Description of Event or Problem · 1

    DURING THE PRODUCT EVALUATION AT BAXTER, IT WAS DISCOVERED THAT A COLLEAGUE INFUSION PUMP HAD A BACK-UP BUZZER FAIL TO AUDIBLY ALARM. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS CURRENTLY UNKNOWN FOR THIS DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1