BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    MDR report key: 1941457 · Received December 29, 2010

    Report

    Report Number
    6000001-2010-06333
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    September 6, 2010
    Report Date
    October 6, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, 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 WAS PERFORMED. THE REPORTED CONDITION OF FAILURE CODE 810:03 WAS CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. NO FURTHER TESTING HAS BEEN COMPLETED AT THIS TIME AND NO REPAIRS HAVE BEEN PERFORMED AS THE REFERENCED DEVICE HAS BEEN REMOVED FROM SERVICE. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. 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 REPORTED A COLLEAGUE PUMP WHICH EXPERIENCED FAILURE CODE 810:03. IT WAS NOT SPECIFIED WHEN OR AT WHAT POINT IN THE PROCESS THE REPORTED CONDITION OCCURRED. REVIEW OF THE DEVICE EVENT HISTORY DETERMINED THAT THIS CONDITION INTERRUPTED DELIVERY. THERE WAS NO DOCUMENTED PATIENT INVOLVEMENT, INJURY, OR MEDICAL INTERVENTION NECESSARY. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.09.90. 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