BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE COLOR PUMP CE FRENCHVERSION TIPLE

    MDR report key: 1932497 · Received December 18, 2010

    Report

    Report Number
    6000001-2010-05942
    Event Type
    Malfunction
    Date Received
    December 18, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 17, 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). EVALUATION SUMMARY: THE CONDITION OF A COLLEAGUE INFUSION PUMP THAT EXPERIENCED A BATTERY DEPLETED ALARM WAS CONFIRMED BY BAXTER PERSONNEL IN THE PUMP?S EVENT HISTORY. THIS CONDITION WAS CAUSED BY DEPLETED MAIN BATTERIES. THIS CONDITION WAS RESOLVED BY REPLACING THE MAIN BATTERIES AND BATTERY HARNESS. ADDITIONAL INFORMATION: THIS INVOLVED A COLLEAGUE P1.5 INFUSION PUMP WITH A USER INTERFACE MODULE MASTER SOFTWARE VERSION 6.63.92. 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).

    Additional Manufacturer Narrative · 1

    (B)(4). A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S. THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    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 THE REPORTED CONDITION AS A BATTERY DEPLETED SET ALARM; WHICH INTERRUPTED DELIVERY. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. THE SOFTWARE VERSION OF THIS DEVICE IS CURRENTLY UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1