BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVACLEAR

    MDR report key: 7907912 · Received September 25, 2018

    Report

    Report Number
    3006552611-2018-00014
    Event Type
    Injury
    Date Received
    September 25, 2018
    Report Date
    November 12, 2018
    Manufacturer
    BAXTER HEALTHCARE - OPELIKA
    Product Code
    KDI
    UDI-DI
    07332414101701
    PMA / PMN Number
    K060195
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RECEIVED, THE SAMPLE WAS ANALYZED FOR PVP/NMP CONTENT PER PROTOCOL AND THE RESULTS WERE WITHIN EXPECTATION. 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.

    Additional Manufacturer Narrative · 1

    THE INITIAL ONSET WAS REPORTED AS ON (B)(6) 2018 AND THEN ON (B)(6) 2018 AND LASTLY THE (B)(6) 2018. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERGOING TREATMENT WITH A REVACLEAR MAX DIALYZER EXPERIENCED HYPERSENSITIVITY REACTIONS. ON THE DATE OF ONSET OF REACTIONS, NO MEDICAL INTERVENTION WAS REPORTED FOR THIS OCCURRENCE. TWO DAYS LATER AND 15 MINUTES INTO TREATMENT WITH THE SAME DIALYZER, THE PATIENT EXPERIENCED A ¿FIRST ANAPHYLACTIC REACTION¿ AND WAS LATER HOSPITALIZED THAT SAME DAY. THE PATIENT WAS TREATED WITH AND AN EPI-PEN (EPINEPHRINE INJECTION). TWO DAYS LATER, THE PATIENT WHILE UNDERGOING TREATMENT WITH THE SAME DEVICE, EXPERIENCED A "SEVERE ANAPHYLACTIC REACTION". THE PATIENT'S SYMPTOMS AT TIME OF REACTION RANGED FROM ¿HIVES, CLOSING OF THROAT, DIFFICULT BREATHING, WEAVING¿. AN EPI-PEN WAS ADMINISTERED AND THE SYMPTOMS DECREASED. AT THE TIME OF THIS REPORT, THE PATIENT WAS STILL HOSPITALIZED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749446 REVACLEAR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - OPELIKA NA C418205501 07332414101701

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R REVACLEAR DIALYZER