BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH

    MDR report key: 1832802 · Received September 13, 2010

    Report

    Report Number
    6000001-2010-03179
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    May 29, 2010
    Report Date
    June 14, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    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). 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 (B)(4). A SERVICE HISTORY REVIEW INDICATES THAT THE DEVICE HAS BEEN PREVIOUSLY SERVICED FOR THE REPORTED CONDITION OF BATTERY ISSUES. (B)(4).

    Additional Manufacturer Narrative · 1

    A 510K NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE THE U.S. AND DOES NOT HAVE A 510K NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S. DEVICE EVALUATION: THE DEVICE WAS EVALUATED ON-SITE AT THE CUSTOMER FACILITY. THE BATTERY DEPLETED ALARM WAS CAUSED BY DEPLETED BATTERIES. THE MAIN BATTERIES WERE REPLACED TO CORRECT THIS CONDITION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4)

    Description of Event or Problem · 1

    BAXTER FIELD SERVICE TECHNICIAN SERVICED A COLLEAGUE DEVICE FOR A BATTERY ISSUE. THE BAXTER FIELD SERVICE TECHNICIAN REPAIRED THE DEVICE ON-SITE. NO PATIENT INJURY OR MEDICAL INTERVENTION OCCURRED. UPON REVIEW OF THE EVENT HISTORY BY BAXTER, IT WAS FOUND THAT A BATTERY DEPLETED ALARM OCCURRED ON (B)(6) 2010 AND CAUSED AN INTERRUPTION OF DELIVERY. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 5.06.00, WHICH IS CATEGORIZED AS UNREMEDIATED.

    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