BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP,COLLEAGUE CXE SINGLECHANNEL COLOUR-LOANER

    MDR report key: 1981750 · Received February 8, 2011

    Report

    Report Number
    6000001-2011-00739
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    September 7, 2010
    Report Date
    September 23, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-12/1/08-002C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    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 SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE HAS BEEN PREVIOUSLY SERVICED FOR THE REPORTED CONDITION. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH MDQ-CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT A COLLEAGUE INFUSION PUMP IN WHICH THE DEVICE HAD A DAMAGED BATTERY. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. DURING BAXTER'S REVIEW OF THE EVENT HISTORY, IT WAS DISCOVERED THAT A BATTERY DEPLETED SET ALARM OCCURRED DURING INFUSION, WHICH CAUSED AN INTERRUPTION DURING DELIVERY. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 6.13.92, CATEGORIZED AS REMEDIATED.

    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