BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSO.R.

    MDR report key: 2904802 · Received January 9, 2013

    Report

    Report Number
    1416980-2013-00675
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    November 30, 2012
    Report Date
    December 18, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K883577
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).EVALUATION SUMMARY:THE REPORTED PROBLEM OF AN INFUSO.R. PUMP WITH A "SHORT IN CIRCUIT BOARD" WAS NOT CONFIRMED SINCE THE DEVICE WAS NOT SENT IN FOR EVALUATION.ADDITIONAL INFORMATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FINDING NO EXCEPTION, NONCONFORMANCE, OR REWORK THAT OCCURRED DURING THE MANUFACTURING OF THE COMPLAINT LOT OR SERIAL NUMBER.A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    THE FACILITY REPORTED AN INFUSO.R. PUMP WITH "SHORT IN CIRCUIT BOARD". THIS EVENT OCCURRED UPON POWER UP IN THE "SURGERY" DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT, PATIENT/USER INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11305 INFUSO.R. PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1