BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, INTRAVASCULAR

    MDR report key: 3821863 · Received May 20, 2014

    Report

    Report Number
    1416980-2014-16284
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Report Date
    April 25, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED SECONDARY SET EXPERIENCED A SIMULTANEOUS FLOW. THE SECONDARY SET WAS CONNECTED TO A NON-BAXTER PRIMARY SET. THE PRIMARY SET DID NOT STOP ¿DRIPPING¿ AND WAS OBSERVED TO HAVE ¿SIPHONED THE SECONDARY BAGS CONTENTS.¿ A SIGMA PUMP WAS BEING USED WITH THE SETS. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300336 SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 HOSPIRA SET, SIGMA INFUSION PUMP