BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIPRO CELLENTIA H DIALYZER

    MDR report key: 22908080 · Received August 27, 2025

    Report

    Report Number
    9610987-2025-00015
    Event Type
    Malfunction
    Date Received
    August 27, 2025
    Date of Event
    July 21, 2025
    Report Date
    April 9, 2026
    Manufacturer
    NIPRO CORPORATION (ODT)
    Product Code
    KDI
    UDI-DI
    00038379008853
    PMA / PMN Number
    K160444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION REPORT ATTACHED IS ON RETAINED SAMPLES BY THE MANUFACTURER ONLY AND 2 UNUSED SAMPLES RETURNED BY THE CUSTOMER..

    Additional Manufacturer Narrative · 0

    PENDING RESPONSE FROM THE CUSTOMER REGARDING SAMPLE AVAILABILITY, TO RETURN TO THE FACTORY FOR INVESTIGATION.

    Description of Event or Problem · 0

    DURING HEMODIALYSIS, APPROXIMATELY 1 HOUR AND 10 MINUTES INTO TREATMENT, MACHINE ALARMED FOR BLOOD LEAK, BUT NURSE SILENCED THE ALARM SEVERAL TIMES. BLOOD LEAK TEST STRIP CONFIRMED POSITIVE FOR BLOOD LEAK. PATIENT DID NOT ENCOUNTER ANY SYMPTOMS WHEN THE LEAK OCCURRED. NO INFORMATION WAS PROVIDED ON THE PATIENT'S HISTORY. DURING TREATMENT PATIENT RECEIVED ESA (ERYTHROPOIESIS-STIMULATING AGENTS) MEDICATION. MACHINE WAS PULLED AND SWITCHED WITH A NEW ONE. DIALYZER LOT #24E0GE LINE LOT #F1YH011, PATIENT WAS ABLE TO COMPLETE THEIR PRESCRIBED TREATMENT. DIALYSIS SETTINGS ARE 4HR RUN TIME, QB AT 400, TMP= 30 TO 95, HEPARIN AT 1000U/1000U. CLINIC STATED THAT THE SAME PATIENT EXPERIENCED ANOTHER DIALYZER LEAK 23 DAYS LATER.

    Description of Event or Problem · 0

    DURING HEMODIALYSIS, APPROXIMATELY 1 HOUR AND 10 MINUTES INTO TREATMENT, MACHINE ALARMED FOR BLOOD LEAK, BUT NURSE SILENCED THE ALARM SEVERAL TIMES. BLOOD LEAK TEST STRIP CONFIRMED POSITIVE FOR BLOOD LEAK. PATIENT DID NOT ENCOUNTER ANY SYMPTOMS WHEN THE LEAK OCCURRED. NO INFORMATION WAS PROVIDED ON THE PATIENT'S HISTORY. DURING TREATMENT PATIENT RECEIVED ESA (ERYTHROPOIESIS-STIMULATING AGENTS) MEDICATION. MACHINE WAS PULLED AND SWITCHED WITH A NEW ONE. DIALYZER LOT #24E0GE LINE LOT #F1YH011, PATIENT WAS ABLE TO COMPLETE THEIR PRESCRIBED TREATMENT. DIALYSIS SETTINGS ARE 4HR RUN TIME, QB AT 400, TMP= 30 TO 95, HEPARIN AT 1000U/1000U. CLINIC STATED THAT THE SAME PATIENT EXPERIENCED ANOTHER DIALYZER LEAK 23 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498548 NIPRO CELLENTIA H DIALYZER DIALYZER KDI NIPRO CORPORATION (ODT) DD+CT-C-21H 24E06E 00038379008853

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O