BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, INTRAVASCULAR

    MDR report key: 3200780 · Received July 1, 2013

    Report

    Report Number
    1416980-2013-16988
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER IS UNKNOWN, THEREFORE A DEVICE ANALYSIS COULD NOT BE PERFORMED, NOR COULD A CAUSE BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AIR WAS OBSERVED IN THE LINE, OF AN UNKNOWN TUBING SET. THIS OCCURRED DURING PATIENT INFUSION WITH A NON-BAXTER INFUSION PUMP. THE REPORTER STATED THAT THE PUMP ALARMED FOR AIR IN THE TUBING AND THERE WERE NO KNOWN TECHNIQUE OR PROCESS ERRORS. THE INFUSION WAS STOPPED IN ORDER TO PREVENT THE AIR FROM REACHING THE PATIENT. THERE WAS NO ADVERSE EVENT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299067 SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 SIGMA SPECTRUM