BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PUMP CE ENGLISH VERSION

    MDR report key: 1930942 · Received December 16, 2010

    Report

    Report Number
    6000001-2010-05881
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 22, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONDITION OF UPSTREAM OCCLUSION ALARM WAS CONFIRMED DUE TO A FAULTY PUMP HEAD MODULE. THE PUMP HEAD MODULE WAS REPLACED TO CORRECT THE REPORTED CONDITION. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A SERVICE REVIEW WAS PERFORMED AND THERE ARE NO SERVICE ACTIVITIES IN THE PREVIOUS 12 MONTHS FOR THIS DEVICE. THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 5.09.90 CATEGORIZED AS REMEDIATED. (B)(4)

    Additional Manufacturer Narrative · 1

    A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.(B)(4)

    Description of Event or Problem · 1

    THIS IS A REPORT FROM BAXTER (B)(4) OF AN UPSTREAM OCCLUSION ALARM EVERY 20 MINUTES ON A COLLEAGUE INFUSION PUMP. IT IS UNKNOWN WHEN THE REPORTED CONDITION OCCURRED. IT IS UNKNOWN IF PATIENT INJURY OR MEDICAL INTERVENTION OCCURRED. THE SOFTWARE VERSION FOR THIS DEVICE IS CURRENTLY NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE PUMP CE ENGLISH VERSION PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1