BEUDAMED
    FDA Adverse Event Summary report: N

    6461500 INFUSOR PUMP (1 LABEL)

    MDR report key: 2040512 · Received April 6, 2011

    Report

    Report Number
    6000001-2011-02597
    Date Received
    April 6, 2011
    Date of Event
    March 31, 2011
    Report Date
    March 31, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K883577
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE CONDITION OF AN INFUSO.R. WITH A "CONSTANT ALARM AFTER THE PUMP HAD STARTED INFUSING DURING PRODUCT EVALUATION" ISSUE WAS CONFIRMED AND REPRODUCED DURING PRODUCT EVALUATION. THE ASSIGNABLE CAUSE WAS DETERMINED TO BE A MOTOR SEPARATED FROM GEARBOX. THE MOTOR WAS REPLACED IN ORDER TO FIX THE REPORTED CONDITION. ADDITIONAL INFORMATION: A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THIS PUMP HAS NOT BEEN PREVIOUSLY SENT TO BAXTER FOR SERVICE OF A REPORTED CONDITION OF A "CONSTANT ALARM."

    Description of Event or Problem · 1

    THE BAXTER SERVICE TECHNICIAN REPORTED FINDING A INFUSOR PUMP WHICH EXPERIENCED A CONSTANT ALARM AFTER THE PUMP HAD STARTED INFUSING DURING PRODUCT EVALUATION, INTERRUPTING DELIVERY. THERE WAS NO PATIENT INVOLVEMENT. 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