BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP,COLLEAGUE CXE SINGLECHANNEL COLOUR-LOANER

    MDR report key: 1970674 · Received January 25, 2011

    Report

    Report Number
    6000001-2011-00443
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Date of Event
    July 7, 2010
    Report Date
    November 9, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-12/1/08-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE CAUSE WAS DEPLETED MAIN BATTERIES. THE MAIN BATTERIES AND HARNESS HAVE BEEN REPLACED. 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). THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 6.13.92, CATEGORIZED AS REMEDIATED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER (B)(4) TO REPORT A COLLEAGUE INFUSION PUMP WITH A DAMAGED BATTERY. DURING THE PRODUCT EVALUATION, IT WAS DISCOVERED THAT A BATTERY DEPLETED SET ALARM OCCURRED DURING INFUSION, WHICH CAUSED AN INTERRUPTION DURING DELIVERY. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP,COLLEAGUE CXE SINGLECHANNEL COLOUR-LOANER PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1