BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH

    MDR report key: 1840830 · Received September 22, 2010

    Report

    Report Number
    6000001-2010-03419
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    July 27, 2010
    Report Date
    August 6, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: A SERVICE HISTORY REVIEW DETERMINED THAT THIS DEVICE HAS NOT PREVIOUSLY BEEN SERVICED BY BAXTER. 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: THE DEVICE WAS REPAIRED ON-SITE BY A BAXTER SERVICE REPAIR TECHNICIAN. A VISUAL EXAMINATION AND FUNCTIONAL TEST WERE PERFORMED. THE ROOT CAUSE OF THE REPORTED CONDITION WAS DETERMINED TO BE A DAMAGED MAIN KEYPAD. THE KEYPAD WAS REPLACED TO REPAIR THIS CONDITION. 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. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT A COLLEAGUE INFUSION PUMP EXPERIENCED FAILURE CODE 500:320 DURING PATIENT USE, INTERRUPTING DELIVERY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE MASTER SOFTWARE VERSION OF THIS DEVICE WAS 5.80.92, WHICH IS CLASSIFIED AS REMEDIATED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    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