BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2853422 · Received November 30, 2012

    Report

    Report Number
    1416980-2012-06275
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 7, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT AVAILABLE SO THE REPORTED CONDITION COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. NO CONCLUSION CAN BE DRAWN FROM THE INVESTIGATION. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO NOT BE AVAILABLE FOR EVALUATION. SINCE THE PRODUCT CODE AND LOT NUMBER OF THE DEVICE INVOLVED ARE UNKNOWN, A 510K NUMBER CANNOT BE PROVIDED AND A BATCH REVIEW CANNOT BE PERFORMED. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED A BAXTER SPECIALIST TO REPORT AN UNKNOWN BURETROL SET IN WHICH AIR IN THE LINE WAS OBSERVED. ACCORDING TO THE REPORT, WHEN ADDING ANTIBIOTICS INTO THE BURETROLS, "SOME SORT OF AIR LOCK WAS HAPPENING", INDICATING AIR IN THE LINE. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INJURY OR ADVERSE EVENT ASSOCIATED WITH THIS EVENT. PATIENT INVOLVEMENT IS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ANTIBIOTICS