BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVACLEAR 400

    MDR report key: 13061052 · Received December 22, 2021

    Report

    Report Number
    3006552611-2021-00014
    Event Type
    Injury
    Date Received
    December 22, 2021
    Date of Event
    November 22, 2021
    Report Date
    February 4, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    UDI-DI
    07332414124076
    PMA / PMN Number
    K130039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    H10: THE ACTUAL SAMPLE WAS RETURNED FOR EVALUATION. PVP AND NMP CONTENT EVALUATION TESTING WAS PERFORMED AND THE DEVICE PASSED. THE REPORTED CONDITION WAS NOT VERIFIED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SIXTEEN (16) MINUTES INTO TREATMENT WITH A REVACLEAR 400, THE PATIENT EXPERIENCED DIFFICULTY BREATHING, PRURITUS, RESTLESSNESS AND LOW BLOOD PRESSURE. TREATMENT WAS DISCONTINUED WITHOUT RETURNING THE EXTRACORPOREAL BLOOD TO THE PATIENT (NO BLOOD PRESSURE VALUES WERE REPORTED).THE PATIENT RECEIVED BENADRYL AND SOLUMEDROL FOR THE EVENTS. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1965904 REVACLEAR 400 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION NA C621400807 07332414124076

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention NORMAL SALINE| TORAY