BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MD - DISPOSABLE

    MDR report key: 1961837 · Received January 14, 2011

    Report

    Report Number
    6000001-2011-00277
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 21, 2010
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE CONDITION COULD NOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. THE PRODUCT CODE OF THIS DEVICE USED IN THIS SITUATION IS UNKNOWN; THEREFORE, IT DOES NOT HAVE A U.S. 510K NUMBER. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO A BAXTER SALES REPRESENTATIVE OF AN UNKNOWN SECONDARY SET THAT HAD A NO FLOW. A SIGMA PUMP WAS USED ALONG WITH THIS SET. THE PROCESS STEP IN WHICH THIS REPORTED CONDITION OCCURRED IS UNKNOWN. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INVOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MD - DISPOSABLE SET, ADMINISTRATION, INTRAVASCULAR FPA UNKNOWN MANUFACTURING FACILITY

    Patients

    Seq Age Sex Outcome Treatment
    1 SIGMA PUMP