BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REF COLLEAGUE CXE SINGLE VOLINFUSTION PUMP W/GUARD FEATURE

    MDR report key: 1872441 · Received October 18, 2010

    Report

    Report Number
    6000001-2010-04108
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 26, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE WAS PREVIOUSLY SERVICED FOR THE REPORTED CONDITION. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION WAS CONFIRMED BUT NOT DUPLICATED. THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED AT THIS TIME. THE DEVICE WAS NOT REPAIRED SINCE IT IS A BAXTER-OWNED UNIT. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT A COLLEAGUE INFUSION PUMP WITH THE REPORTED CONDITION "FAILURE"; AFTER TALKING TO THE CONTACT IT WAS SPECIFIED THAT FAILURE CODE 500:320:654:0000 WAS THE REPORTED CONDITION. THE FACILITY REPRESENTATIVE STATED THAT THERE WERE NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE. DURING THE PRODUCT EVALUATION AT BAXTER, IT WAS DISCOVERED THAT FAILURE CODE 500:320:654:0000 OCCURRED DURING INFUSION WHICH CAUSED AN INTERRUPTION DURING DELIVERY. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION FOR THIS DEVICE IS 6.13.90, CATEGORIZED AS REMEDIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REF COLLEAGUE CXE SINGLE VOLINFUSTION PUMP W/GUARD FEATURE PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1