BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CXE VOLUMETRICINFUSION PUMP

    MDR report key: 1760244 · Received July 16, 2010

    Report

    Report Number
    6000001-2010-01726
    Event Type
    Malfunction
    Date Received
    July 16, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 9, 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE FOR THIS ISSUE IS CURRENTLY BEING INVESTIGATED THROUGH CAPA (CORRECTIVE AND PREVENTIVE ACTION) INVESTIGATION MDQ-CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE GREY COLORED HYDROCANISTER LID OF THE UNICEL DXC 800 SYNCHRON CHEMISTRY ANALYZER CRACKED. NO INJURY WAS REPORTED.

    Description of Event or Problem · 1

    THE SERVICE TECHNICIAN FOUND A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 810:11 CAUSED BY AIL (AIR IN LINE) OUT OF CALIBRATION AND HAD TO BE RECALIBRATED. THIS EVENT OCCURRED DURING SERVICE. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE.THE USER INTERFACE MODULE MASTER SOFTWARE VERSION FOR THIS DEVICE IS 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