BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6461500 INFUSOR PUMP (1 LABEL)

    MDR report key: 2024181 · Received March 18, 2011

    Report

    Report Number
    6000001-2011-01973
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 28, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K883577
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SERVICE HISTORY WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS REPORTED PROBLEM FOR THIS PUMP. DEVICE EVALUATION: THE REPORTED CONDITION OF AN ALARM WITHIN 3 TO 5 MINUTES OF INFUSION INVOLVING AN INFUSO.R. PUMP WAS CONFIRMED AND REPRODUCED DURING DEVICE EVALUATION. THE ASSIGNABLE CAUSE WAS DETERMINED TO BE A DAMAGED MICRO-PROCESSOR UNIT (MPU) BOARD. THE MPU BOARD WAS REPLACED TO FIX THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY AWAITING EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPORTED AN INFUSOR PUMP WHICH "WILL BE IN USE AND THEN SUDDENLY AN ALARM COMES ON." THIS CONDITION WAS IDENTIFIED IN THE ANESTHESIA DEPARTMENT. THE REPORTED CONDITION OCCURRED DURING USE AND STOPPED PATIENT THERAPY. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6461500 INFUSOR PUMP (1 LABEL) PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1