BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFURBED COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNE

    MDR report key: 2001823 · Received February 25, 2011

    Report

    Report Number
    6000001-2011-01351
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    July 1, 2009
    Report Date
    February 8, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE OF THE REPORTED PROBLEM WAS DETERMINED TO BE DEFECTIVE PUMP HEAD MODULE. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CONDITION OF 812:04 WAS CONFIRMED THROUGH THE EVALUATION. 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. (B)(4).

    Description of Event or Problem · 1

    DURING SERVICE BY BAXTER, THE COLLEAGUE INFUSION PUMP WAS FOUND TO CONTAIN A MALFUNCTION OF FAILURE CODE 812:04. THIS EVENT OCCURRED DURING PRODUCT EVALUATION. SERVICE DETERMINED THAT THIS FAILURE INTERRUPTED DELIVERY. NO ADDITIONAL INFORMATION WAS AVAILABLE. THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 5.09.90 CATEGORIZED AS REMEDIATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1