BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CXE VOLUMETRIC INFUSION PUMP SINGLE CHANNEL RECERT

    MDR report key: 1914778 · Received December 4, 2010

    Report

    Report Number
    6000001-2010-05515
    Event Type
    Malfunction
    Date Received
    December 4, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 20, 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). DEVICE EVALUATION: THIS DEVICE WAS RETURNED TO BAXTER FOR EVALUATION. A VISUAL INSPECTION AND FUNCTIONAL TESTS WERE PERFORMED. DEVICE EVALUATION CONFIRMED THE REPORTED CONDITION AS FAILURE CODE 810:11. THE ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. NO REPAIRS WERE PERFORMED AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS CUSTOMER SERVICE REQUEST ON THIS PUMP. 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).

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 810:11 UPON POWER-UP OF THE DEVICE DURING BIOMED SERVICE. THE FACILITY REPRESENTATIVE STATED THAT THERE WERE NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION. BAXTER'S REVIEW OF THE DEVICE EVENT HISTORY DETERMINED THE REPORTED CONDITION INTERRUPTED DELIVERY. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 6.13.90, 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 CXE VOLUMETRIC INFUSION PUMP SINGLE CHANNEL RECERT PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1