BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE COLOR PUMP CE FRENCHVERSION SINGLE

    MDR report key: 1920406 · Received December 10, 2010

    Report

    Report Number
    6000001-2010-05745
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    August 27, 2010
    Report Date
    October 7, 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THIS DEVICE WAS EVALUATED ONSITE AT THE FACILITY BY A BAXTER TECHNICIAN. A VISUAL INSPECTION AND FUNCTIONAL TESTS WERE PERFORMED. DEVICE EVALUATION CONFIRMED THE REPORTED CONDITION AS A BATTERY DEPLETED ALARM . THE ROOT CAUSE OF THE REPORTED PROBLEM WAS DETERMINED TO BE DEPLETED MAIN BATTERIES. A BAXTER REPAIR TECHNICIAN REPLACED THE MAIN BATTERIES AND HARNESS TO RESOLVE THIS ISSUE. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT A COLLEAGUE INFUSION PUMP EXPERIENCED A BATTERY ISSUE. BAXTER'S REVIEW OF THE DEVICE EVENT HISTORY DETERMINED A BATTERY DEPLETED ALARM INTERRUPTED DELIVERY. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 6.63.92, WHICH IS CLASSIFIED AS REMEDIATED. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1