BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CXE VOLUMETRICINFUSION PUMP

    MDR report key: 2040491 · Received April 5, 2011

    Report

    Report Number
    6000001-2011-02590
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 28, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-12/1/08-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION OF FAILURE CODE 703:00 WAS CONFIRMED BUT NOT DUPLICATED AND WAS FOUND TO BE DUE TO A COMMUNICATION CONNECTION SIGNAL PROBLEM. THE COMMUNICATION HARNESSES WERE REPLACED TO CORRECT THE REPORTED CONDITION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    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). THE DEVICE HAS BEEN PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION OF (B)(4).

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 703. IT IS UNKNOWN WHEN THIS EVENT OCCURRED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, INJURY, OR MEDICAL INTERVENTION NECESSARY. THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 6.13.90 CATEGORIZED AS REMEDIATED. DURING REVIEW OF THE EVENT HISTORY BY BAXTER IT WAS DETERMINED THAT THE REPORTED CONDITION OCCURRED ON CHANNEL A DURING DELIVERY CAUSING AN INTERRUPTION OF DELIVERY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CXE VOLUMETRICINFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1