BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH

    MDR report key: 1873197 · Received October 18, 2010

    Report

    Report Number
    6000001-2010-04184
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    June 16, 2010
    Report Date
    September 29, 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). EVALUATION RESULTS: FAILURE CODE 808:03 THAT CAUSED AN INTERRUPTION OF DELIVERY WAS CONFIRMED FROM THE EVENT HISTORY BY BAXTER CANADA. THE CAUSE OF THE DETERMINED MALFUNCTION WAS FOUND TO BE A DEFECTIVE PUMP HEAD MODULE, DUE TO SPILLED LIQUID. THE PHM WAS REPLACED TO FIX THE REPORTED CONDITION. ADDITIONAL INFORMATION: SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH CAPA'S (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER FOR EVALUATION; HOWEVER, THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR SHOULD ADDITIONAL INFORMATION BECOME 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.

    Description of Event or Problem · 1

    AFTER THE DEVICE WAS RECEIVED FOR EVALUATION BY BAXTER CANADA, A REVIEW OF THE EVENT HISTORY REVEALED THAT FAILURE CODE 808:03 INTERRUPTED DELIVERY. THERE WAS NO REPORTED PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS INVOLVED A COLLEAGUE P1.5 INFUSION PUMP WITH USER INTERFACE MODULE MASTER SOFTWARE VERSION 5.08.92.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT A COLLEAGUE INFUSION PUMP EXPERIENCED FAILURE CODE 808:03. DURING A REVIEW OF THE PUMP'S EVENT HISTORY BY BAXTER PERSONNEL, IT WAS DETERMINED THAT THE REPORTED CONDITION INTERRUPTED DELIVERY. THE PROCESS STEP IS UNKNOWN, AND THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. THE SOFTWARE VERSION OF THIS DEVICE IS CURRENTLY UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ON (B)(6) 2010, A CUSTOMER REPORTED THAT THE COLLEAGUE VOLUMETRIC INFUSION PUMP, PRODUCT CODE DNM8151, (B)(4), HAS A PROBLEM WITH THE AUDIO CIRCUIT. THE PROCESS STEP IS UNKNOWN, AND THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. THE DEVICE WILL BE RETURNED TO (B)(4) FOR EVALUATION UNDER (B)(4). UPON REVIEW OF THE EVENT HISTORY REPORT FOR (B)(4) ON (B)(6) 2010, IT WAS FOUND THAT FC 808:03 CAUSED THE DEVICE TO STOP DURING INFUSION ON (B)(6) 2010. THIS IS A REPORTABLE MALFUNCTION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. THIS COMPLAINT IS BEING INITIATED TO ADDRESS THIS ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1