BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH

    MDR report key: 1905723 · Received November 23, 2010

    Report

    Report Number
    6000001-2010-05161
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    August 23, 2010
    Report Date
    September 13, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    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 DEFECTIVE MAIN BATTERIES. THE MAIN BATTERIES AND HARNESS HAVE BEEN REPLACED. HAS BEEN PROVIDED WITH NA (NOT APPLICABLE). THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 5.08.92, CATEGORIZED AS REMEDIATED. A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE WAS PREVIOUSLY SERVICED FOR THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN EVALUATED ONSITE. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510K NUMBER. THIS INCIDENT IS BEING REPORT BECAUSE THE DEVICE INVOLVED IS THE SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S. THIS MDR WAS SUBMITTED ON (B)(6) 2010; HOWEVER, DUE TO A FAILURE TO RECEIVE ACKNOWLEDGEMENTS, THIS MDR IS BEING RESUBMITTED ON (B)(6) 2010.

    Description of Event or Problem · 1

    THE BAXTER FIELD SERVICE TECHNICIAN SERVICED A COLLEAGUE INFUSION PUMP FOR A BATTERY ISSUE. 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 CURRENTLY UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1