BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    MDR report key: 2032812 · Received March 29, 2011

    Report

    Report Number
    6000001-2011-02310
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 16, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-3/15/05-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    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 MDQ-CAPA (B)(4). A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THIS DEVICE WAS RETURNED TO BAXTER FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED. THE REPORTED CONDITION OF AN 810:11 FAILURE CODE WAS CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. NO FURTHER TESTING HAS BEEN COMPLETED AT THIS TIME AND NO REPAIRS HAVE BEEN PERFORMED AS THE REFERENCED DEVICE HAS BEEN REMOVED FROM SERVICE. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. REVIEW OF THE EVENT HISTORY DETERMINED THAT THE REPORTED CONDITION OCCURRED ON (B)(6) 2010 NOT ON THE REPORTED OCCURRENCE DATE OF (B)(6) 2010.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WHICH EXPERIENCED AN 810:11 FAILURE CODE. IT IS UNKNOWN WHICH PROCESS STEP THIS EVENT OCCURRED DURING. UPON REVIEW OF THE EVENT HISTORY, QUALITY ENGINEERING DETERMINED THAT THIS EVENT INTERRUPTED DELIVERY. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, AND THEREFORE NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.09.90. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1