BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REF COLLEAGUE CXE SINGLE VOLINFUSTION PUMP W/GUARD FEATURE

    MDR report key: 1904714 · Received November 22, 2010

    Report

    Report Number
    6000001-2010-05033
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    September 3, 2010
    Report Date
    October 29, 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 TREND REVIEW HAS BEEN PERFORMED AND IT WAS DISCOVERED THAT SIMILAR REPORTS HAVE BEEN MADE TO BAXTER. THE ROOT CAUSE IS CURRENTLY IN PROGRESS THROUGH MDQ-CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION WAS CONFIRMED AND DUPLICATED. THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED AT THIS TIME. THE UNIT IS A STAY-IN DEVICE AND WILL NOT BE REPAIRED AT THIS TIME. ADDITIONAL: A SERVICE HISTORY REVIEW HAS BEEN PERFORMED AND THE DEVICE WAS PREVIOUSLY SERVICED FOR THE REPORTED CONDITION.

    Description of Event or Problem · 1

    DURING A REVIEW OF THE EVENT HISTORY FOR ANOTHER REPORT OF A COLLEAGUE INFUSION PUMP, IT WAS DISCOVERED THAT FAILURE CODE 812:02 OCCURRED DURING INFUSION WHICH CAUSED AN INTERRUPTION DURING DELIVERY ON (B)(6) 2010. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE. 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