BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 CXE VOLUMETRICINFUSION PUMP

    MDR report key: 1904994 · Received November 22, 2010

    Report

    Report Number
    6000001-2010-05139
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    September 18, 2010
    Report Date
    September 23, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Removal / Correction Number
    6000001-12/1/08-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN EVALUATED ONSITE. THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE CAUSE HAS BEEN DETERMINED TO BE DEPLETED MAIN BATTERIES. THE MAIN BATTERIES AND HARNESS WERE REPLACED. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2010 THE BAXTER FIELD SERVICE TECHNICIAN SERVICED A COLLEAGUE INFUSION PUMP FOR A BATTERY ISSUE. DURING BAXTER'S REVIEW OF THE EVENT HISTORY ON (B)(6) 2010 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 3 CXE VOLUMETRICINFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1