BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH

    MDR report key: 1914775 · Received December 3, 2010

    Report

    Report Number
    6000001-2010-05509
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    September 16, 2010
    Report Date
    October 6, 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 ONSITE AT THE FACILITY BY A BAXTER FIELD SERVICE TECHNICIAN BY REPLACING THE MAIN BATTERIES AND BATTERY HARNESS. THIS DEVICE IS AN UNREMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.06.00. 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). DEVICE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED UPON RECEIPT OF THE EVALUATION RESULTS OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE. 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.

    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 DEPLETED SET ALARM; WHICH INTERRUPTED DELIVERY. THE USER INTERFACE MODULE SOFTWARE VERSION OF THIS PUMP IS CURRENTLY UNKNOWN. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ON (B)(6) 2010, THE BAXTER FIELD SERVICE TECHNICIAN SERVICED A COLLEAGUE DEVICE, PRODUCT CODE DNM8151, (B)(4), FOR A BATTERY ISSUE. PATIENT INJURY/MEDICAL INTERVENTION WAS NOT REPORTED TO HAVE OCCURRED. THE BAXTER FIELD SERVICE TECHNICIAN REPAIRED THE DEVICE ON SITE. AS SUCH, THE DEVICE WILL NOT BE RETURNED TO CANADIAN TECHNICAL SERVICES. UPON REVIEW OF THE EVENT HISTORY FOR (B)(4) IT WAS FOUND THAT THIS DEVICE ENCOUNTERED A 'BATTERY DEPLETED SET' ALARM DURING AN INFUSION ON (B)(6), (B)(6), AND (B)(6) 2010. ALSO FAILURE CODE 570:320:625:0000 INTERRUPTED A DELIVERY ON (B)(6) 2010. SINCE THE ALARMS STOPPED THE INFUSION IN EACH CASE, THESE COMPLAINTS WILL BE REPORTED FOR AN INTERRUPTION OF DELIVERY WHICH IS A REPORTABLE MALFUNCTION. THIS COMPLAINT WILL ADDRESS THE SECOND BATTERY DEPLETED ALARM ON (B)(6) 2010. THE EVENT HISTORY WAS REVIEWED ON (B)(6) 2010.

    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