BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIPRO ELISIO-H DIALYZER

    MDR report key: 22580335 · Received July 23, 2025

    Report

    Report Number
    9610987-2025-00014
    Event Type
    Injury
    Date Received
    July 23, 2025
    Report Date
    August 29, 2025
    Manufacturer
    NIPRO CORPORATION (ODT)
    Product Code
    KDI
    PMA / PMN Number
    K131935
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING LOT INFORMATION AND ADDITIONAL INFORMATION ABOUT THE EVENT, AS WELL AS SAMPLE AVAILABILITY.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED FROM FACILITY ON JULY 23 AND AUGUST 1, WITH A POSSIBLE LOT NUMBER, UNKNOWN IF IT WAS THE ACTUAL LOT IN QUESTION. DETAILS ADDED TO THE APPROPRIATE SECTIONS OF THE FORM.

    Description of Event or Problem · 0

    CUSTOMER REPORTED A DECREASE IN BLOOD PRESSURE FROM 150MMHG TO 50MMHG DURING THE USE OF THE DIALYZER. AN INCREASE IN EOSINOPHILS WAS ALSO OBSERVED. SAME PATIENT EXPERIENCED SIMILAR EVENT WITH THEIR SECOND TREATMENT. A DECREASE IN BLOOD PRESSURE FROM 180MMHG TO 50MMHG. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. DATE OF OCCURRENCE IS UNKNOWN.

    Description of Event or Problem · 0

    CUSTOMER REPORTED A DECREASE IN BLOOD PRESSURE FROM 150MMHG TO 50MMHG DURING THE USE OF THE DIALYZER. AN INCREASE IN EOSINOPHILS WAS ALSO OBSERVED. SAME PATIENT EXPERIENCED SIMILAR EVENT WITH THEIR SECOND TREATMENT. A DECREASE IN BLOOD PRESSURE FROM 180MMHG TO 50MMHG. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. DATE OF OCCURRENCE IS UNKNOWN. ADDITIONAL INFORMATION RECEIVED JULY 23: EVENT OCCURRED IMMEDIATELY AFTER THE START OF TREATMENT. TOTAL OF 2 INCIDENTS. AFTER THE SECOND INCIDENT, THEY WERE SET UP ON ANOTHER MACHINE WITH A PES MEMBRANE DIALYZER INSTEAD, SYMPTOMS THEN STARTED TO IMPROVE. ADDITIONAL INFORMATION RECEIVED AUGUST 1: 1ST INCIDENT: CONTINUOUS ADMINISTRATION OF 50 ML OF NORMAL SALINE+ EHOTIL 2A, 100 ML OF FLUID REPLACEMENT, OXYGEN ADMINISTRATION AT 5 L (M) FOR 5 MINUTES (PRE-ADMINISTRATION SPO2: 90%, DURING ADMINISTRATION: 92%, THEN 96% WITH OXYGEN REDUCED), OXYGEN ADMINISTRATION AT 2.5 L FOR 1 HOUR AND 55 MINUTES (SPO2: 97% AT THE END OF DIALYSIS WITH ROOM AIR) 2ND INCIDENT: CONTINUOUS INFUSION OF 50 ML OF NORMAL SALINE + EHOTIL 2A, BLOOD PRESSURE (BP) DECREASED FROM 150 TO 70 WITHIN 32 MINUTES OF DIALYSIS INITIATION, 100 ML OF FLUID REPLACEMENT, CESSATION OF FLUID REMOVAL, 10 MINUTES LATER BP DECREASED FROM 50 TO 200 ML/MIN TO 150 ML/MIN. SPO2: 89%, OXYGEN ADMINISTERED AT 3 L (48 MINUTES), OXYGEN ADMINISTERED AT 2 L (20 MINUTES), THEN SWITCHED FROM PES-11E[?]ECO TO APS-13SA AFTER 20 MINUTES, WITH BP REMAINING BETWEEN 90 AND 120. THE OCCURRENCE DATE: 1ST INCIDENT: (B)(6) 2025. 2ND INCIDENT: (B)(6) 2025. ESTIMATED LOT NUMBER 23H24C.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57999 NIPRO ELISIO-H DIALYZER DIALYZER KDI NIPRO CORPORATION (ODT) ELISIO-11H UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other