BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVACLEAR 400

    MDR report key: 12144128 · Received July 9, 2021

    Report

    Report Number
    9611369-2021-00151
    Event Type
    Injury
    Date Received
    July 9, 2021
    Date of Event
    April 28, 2021
    Report Date
    August 20, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    UDI-DI
    07332414114923
    PMA / PMN Number
    K130039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION ADDED TO H6 AND H10: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS 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 · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TREATMENT WITH A REVACLEAR 400 DIALYZER, THE PATIENT EXPERIENCED AN ALLERGIC REACTION MANIFESTED AS TREMORS, RASH, COUGH, CHEST PAIN, ITCHY THROAT AND DYSPNEA. THE PATIENT WAS TREATED WITH HYDROCORTISONE, A NEBULIZER (NBZ ) AND O2 THROUGH A NASAL CATHETER. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043592 REVACLEAR 400 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION NA 0-9437-H-01 07332414114923

    Patients

    Seq Age Sex Outcome Treatment
    1 Other