BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLUTION SET

    MDR report key: 17873260 · Received October 4, 2023

    Report

    Report Number
    1416980-2023-05030
    Event Type
    Malfunction
    Date Received
    October 4, 2023
    Report Date
    November 8, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K203609
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION MADE TO D4: LOT: SUSPECTED LOTS R23C02079 AND R22H23109 . D4: EXPIRATION DATE FOR SUSPECTED LOT R23C02079: 3/3/2025 D4: EXPIRATION DATE FOR SUSPECTED LOT R22H23109: 8/24/2028 H4: DEVICE MANUFACTURE DATE FOR SUSPECTED LOT R23C02079: 3/3/2023 H4: DEVICE MANUFACTURE DATE FOR SUSPECTED R22H23109: 8/24/2022. H10: A BATCH REVIEW WAS CONDUCTED FOR SUSPECTED LOTS R23C02079 AND R22H23109 AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THESE LOTS. THE DEVICES WERE NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF SOLUTION SETS HAD AIR RESULTING IN UPSTREAM OCCLUSION ALARMS ON THE PUMP. THE ISSUE WAS IDENTIFIED DURING PATIENT INFUSION WITH UNSPECIFIED MEDICATION, TOWARDS THE END OF THERAPY (EMPTY BAG, BUT THERE IS STILL LIQUID IN THE TUBE). THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467401 SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NOVUM IQ LVP PUMP.