BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CXE VOLUMETRICINFUSION PUMP

    MDR report key: 1750035 · Received July 9, 2010

    Report

    Report Number
    6000001-2010-01060
    Event Type
    Malfunction
    Date Received
    July 9, 2010
    Date of Event
    May 16, 2010
    Report Date
    May 17, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION OF FAILURE CODE 38:309:914:0002 WAS CONFIRMED BUT COULD NOT BE DUPLICATED. THE FAILURE CODE OCCURRED ONCE IN EVENT HISTORY. THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. THE DEVICE WAS POWERED OFF AND BACK ON, FAILURE DID NOT REOCCUR, NO REPAIR REQUIRED. (B)(4).

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WITH A FAILURE CODE OF 38:309:914:0002. IT IS UNKNOWN WHEN THIS EVENT OCCURRED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE. DURING BAXTER REVIEW OF THE EVENT HISTORY ON (B)(4) 2010 IT WAS DETERMINED THAT THE REPORTED CONDITION OCCURRED DURING DELIVERY. 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