BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CXE VOLUMETRICINFUSION PUMP

    MDR report key: 2070083 · Received April 26, 2011

    Report

    Report Number
    6000001-2011-03207
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    February 4, 2011
    Report Date
    March 18, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH A BATTERY DEPLETED SET ALARM WAS FOUND TO HAVE RESULTED FROM USER ERROR. A DEVICE HISTORY REVIEW WAS PERFORMED WITH NO EXCEPTIONS DURING MANUFACTURING FOUND.

    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). THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE CONDITION WAS CONFIRMED. THIS COMPLAINT IS AN ANCILLARY SERVICE EVENT OPENED DURING INVESTIGATION OF (B)(4). THE CAUSE WAS DETERMINED TO BE DAMAGED MAIN BATTERIES. TO CORRECT THE CONDITION, THE MAIN BATTERIES WERE REPLACED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    DURING BAXTER'S REVIEW OF THE EVENT HISTORY FOR ANOTHER REPORT, 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 6.13.92, CATEGORIZED AS REMEDIATED.

    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