BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CXE VOLUMETRICINFUSION PUMP

    MDR report key: 1894488 · Received November 9, 2010

    Report

    Report Number
    6000001-2010-04786
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    September 15, 2010
    Report Date
    October 15, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    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 BUT NOT DUPLICATED. THE ROOT CAUSE WAS NOT IDENTIFIED. NO FURTHER TESTING HAS BEEN COMPLETED AT THIS TIME AND NO REPAIRS HAVE BEEN PERFORMED AS THE REFERENCED DEVICE HAS BEEN REMOVED FROM SERVICE. ADDITIONAL: A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE HAS NOT BEEN PREVIOUSLY SERVICED FOR THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    DURING A REVIEW OF THE EVENT HISTORY OF ANOTHER REPORT FOR A COLLEAGUE INFUSION PUMP, IT WAS DISCOVERED THAT FAILURE CODE 568:320:654:0000 OCCURRED ONCE 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 FOR THIS DEVICE IS 6.13.90, CATEGORIZED AS REMEDIATED.

    Description of Event or Problem · 1

    DURING AN ONSITE VISIT, AN FIELD SERVICE ENGINEER (FSE) FROM BECKMAN COULTER, INC (BCI) DISCOVERED THAT THERE WAS AN INCIDENT OF CHEMICAL EXPOSURE IN THE LABORATORY. A LABORATORY TECHNICIAN WAS INVESTIGATING A SOURCE OF LEAK IN THE HYDRO PNEUMATIC AREA OF UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER, AND WAS UNAWARE THAT THE POTASSIUM HYDROXIDE (WASH CONCENTRATE II) SOLUTION HAD BEEN SPILLED ONTO THE LATCH THAT ALLOWS ACCESS TO THE HYDRO PNEUMATIC COMPONENTS. THE LAB TECH WAS NOT WEARING GLOVES WHEN CAME IN CONTACT WITH POTASSIUM HYDROXIDE SOLUTION, WHICH CAUSED CHEMICAL BURNS ON SEVERAL FINGERS. THE LAB TECH WAS EVALUATED BY THE EMERGENCY DEPARTMENT AND RELEASED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1