BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1943047 · Received December 30, 2010

    Report

    Report Number
    6000001-2010-06484
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    December 9, 2010
    Report Date
    December 9, 2010
    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). 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).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION WAS CONFIRMED BUT NOT DUPLICATED. THE ASSIGNABLE CAUSE WAS DISCONNECTED MAIN SPEAKER HARNESS. THE SPEAKER HARNESS HAS BEEN RECONNECTED. 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).A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    DURING THE PRODUCT EVALUATION AT BAXTER, IT WAS DISCOVERED THAT FAILURE CODE 550:320:844:0000 OCCURRED ON A COLLEAGUE INFUSION PUMP ON POWER-UP. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THERE WAS A FAILURE TO AUDIBLY ALARM. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE. THE USER INTERFACE MODULE MASTER VERSION 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