BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CXE VOLUMETRICINFUSION PUMP

    MDR report key: 2052339 · Received April 12, 2011

    Report

    Report Number
    6000001-2011-02801
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    June 24, 2010
    Report Date
    March 18, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONDITION OF FAILURE CODE 812:01 WAS CONFIRMED THROUGH THE EVENT HISTORY. THE ROOT CAUSE HAS NOT BEEN 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. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE WAS DETERMINED BY SERVICE TO BE NOT IDENTIFIED. NO FURTHER TESTING HAS BEEN COMPLETED AT THIS TIME AND NO REPAIRS HAVE BEEN PERFORMED AS THE REFERENCED DEVICE HAS BEEN REMOVED FROM SERVICE. THE DEVICE HAS NOT BEEN PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION OF " FAILURE CODE 812:01".

    Description of Event or Problem · 1

    DURING REVIEW OF THE EVENT HISTORY BY BAXTER IT WAS DETERMINED THAT A FAILURE CODE 812:01 OCCURRED ON (B)(6) 2010, DURING DELIVERY CAUSING AN INTERRUPTION OF DELIVERY. NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THIS DEVICE. THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 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