BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CXE VOLUMETRICINFUSION PUMP

    MDR report key: 1905287 · Received November 22, 2010

    Report

    Report Number
    6000001-2010-05163
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    July 17, 2010
    Report Date
    September 30, 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
    CA, 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

    THE REPORTED CONDITION OF FAILURE CODE 810:11 WAS CONFIRMED BUT NOT DUPLICATED DUE TO AN OUT OF CALIBRATION AIL PCB (AIR-IN-LINE PRINTED CIRCUIT BOARD). THE AIL PCB WAS RECALIBRATED TO CORRECT THE REPORTED CONDITION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4)

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: DURING REVIEW OF THE EVENT HISTORY BY BAXTER IT WAS DETERMINED THAT THE REPORTED CONDITION OCCURRED ON (B)(4), 2010. (B)(4)

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED A TECHNICAL SERVICE REPRESENTATIVE TO REPORT A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 810:11, WHICH OCCURED DURING PROGRAMMING/SETUP. THE FACILITY REPRESENTATIVE STATED THAT THERE WERE NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE. 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 DURING DELIVERY CAUSING AN INTERRUPTION OF DELIVERY.

    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