BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    MDR report key: 1831571 · Received September 11, 2010

    Report

    Report Number
    6000001-2010-03153
    Event Type
    Malfunction
    Date Received
    September 11, 2010
    Date of Event
    July 7, 2010
    Report Date
    July 7, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE ROOT CAUSE INVESTIGATION FOR THE REPORTED PROBLEM IS IN PROGRESS THROUGH MDQ-CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE WAS RECEIVED BY BAXTER FOR EVALUATION. A VISUAL EXAMINATION AND FUNCTIONAL TESTS WERE PERFORMED. DEVICE EVALUATION CONFIRMED FAILURE CODE 813:01. THE ROOT CAUSE COULD NOT BE DETERMINED AND NO REPAIRS PERFORMED, AS THIS IS A STAY-IN DEVICE. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE PUMP WITH A FAILURE CODE OF 813:01. IT WAS NOT SPECIFIED WHEN REPORTED CONDITION OCCURRED; HOWEVER , REVIEW OF THE DEVICE EVENT HISTORY DETERMINED THAT A CASCADE FAILURE FROM THIS CONDITION, FAILURE CODE 808:02, INTERRUPTED DELIVERY. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 6.13.90, WHICH IS CLASSIFIED AS REMEDIATED. THERE WAS NO DOCUMENTED PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1