BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    MDR report key: 1844318 · Received September 24, 2010

    Report

    Report Number
    6000001-2010-03516
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 29, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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 OF FAILURE CODE 808:02. REVIEW OF THE DEVICE EVENT HISTORY DETERMINED THAT THE REPORTED CONDITION OF OCCURRED ON (B)(6) 2010 AND NOT THE CUSTOMER REPORTED OCCURRENCE DATE OF (B)(6) 2010. THE ROOT CAUSE HAS NOT DETERMINED AT THIS TIME. NO REPAIRS HAVE BEEN PERFORMED AT THIS TIME SINCE THIS IS A BAXTER OWNED DEVICE. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ROOT CAUSE INVESTIGATION FOR THE REPORTED PROBLEM IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE PUMP WITH A FAILURE. IT WAS NOT SPECIFIED WHEN REPORTED CONDITION OCCURRED. BAXTER'S DEVICE EVALUATION, INCLUDING EVENT HISTORY REVIEW, CONFIRMED THE REPORTED CONDITION OF A PUMP FAILURE AS FAILURE CODE 808:02, WHICH INTERRUPTED DELIVERY. THERE WAS NO DOCUMENTED PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 5.09.90, 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 CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1