BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    MDR report key: 1820431 · Received August 30, 2010

    Report

    Report Number
    6000001-2010-02869
    Event Type
    Malfunction
    Date Received
    August 30, 2010
    Date of Event
    June 10, 2010
    Report Date
    August 11, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION: THE EVALUATION RESULTS WERE INADVERTENTLY OMITTED IN THE INITIAL MEDWATCH REPORT. THE REPORTED CONDITION WAS CONFIRMED AND DUPLICATED. THE ASSIGNABLE CAUSE WAS A FAULTY PHM (PUMPHEAD MODULE). THE PHM HAS BEEN REPLACED. ADDITIONAL: 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).

    Description of Event or Problem · 1

    DURING A REVIEW OF THE EVENT HISTORY, FAILURE CODE 808:02 OCCURRED ONE TIME ON (B)(6) 2010 DURING INFUSION. THERE WAS AN INTERRUPTION DURING DELIVERY. 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 (B)(4) CATEGORIZED AS REMEDIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1