BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CXE VOLUMETRICINFUSION PUMP

    MDR report key: 1875260 · Received October 19, 2010

    Report

    Report Number
    6000001-2010-04300
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 29, 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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    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 MDQ-CAPA-(B)(4). THE DEVICE HAS BEEN PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION OF FC 810:11. (B)(4)

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION OF FAILURE CODE 810:11 WAS CONFIRMED THROUGH THE EVENT HISTORY, BUT NOT DUPLICATED. THE REPORTED CONDITION IS DUE TO THE AIL PCB (AIR-IN-LINE PRINTED CIRCUIT BOARD) BEING OUT OF CALIBRATION. THE AIL PCB WAS RECALIBRATED TO CORRECT THE REPORTED CONDITION. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    DURING BAXTER'S REVIEW OF THE EVENT HISTORY, IT WAS DISCOVERED THAT FAILURE CODE 810:11 OCCURRED ON (B)(6) 2010 DURING DELIVERY CAUSING AN INTERRUPTION OF DELIVERY. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THIS DEVICE. THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 6.13.90 CATEGORIZED AS REMEDIATED.

    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