BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS

    MDR report key: 21752541 · Received April 2, 2025

    Report

    Report Number
    0008030665-2025-00745
    Event Type
    Injury
    Date Received
    April 2, 2025
    Date of Event
    March 25, 2025
    Report Date
    April 2, 2025
    Manufacturer
    ERIKA DE REYNOSA, S.A. DE C.V.
    Product Code
    KDI
    UDI-DI
    00840861100859
    PMA / PMN Number
    K153449
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL INVESTIGATION: A TEMPORAL RELATIONSHIP EXISTS BETWEEN HD THERAPY UTILIZING A 2008K2 HEMODIALYSIS SYSTEM AND THE SERIOUS ADVERSE EVENTS OF A LOSS OF CONSCIOUSNESS DUE TO INTRADIALYTIC HYPOTENSION, WHICH REQUIRED THE TERMINATION OF HD THERAPY AND THE ADMINISTRATION OF A VASOPRESSOR FOR BLOOD PRESSURE SUPPORT. INTRADIALYTIC HYPOTENSION IS THE MOST PREVALENT COMPLICATION ASSOCIATED WITH HD, OCCURRING IN APPROXIMATELY 25% OF ALL TREATMENTS. VERY OFTEN, THE CAUSE OF INTRADIALYTIC HYPOTENSION IS MULTIFACTORIAL IN ORIGIN. PER THE ICN, THE SERIOUS ADVERSE EVENTS WERE UNRELATED TO ANY FRESENIUS DEVICE AND/OR PRODUCT MALFUNCTION OR DEFICIENCY. BASED ON THE INFORMATION AVAILABLE, THE 2008K2 HEMODIALYSIS SYSTEM CAN BE DISASSOCIATED FROM THE SERIOUS ADVERSE EVENTS. THERE IS NO ALLEGATION OR OBJECTIVE EVIDENCE INDICATING A FRESENIUS DEVICE AND/OR PRODUCT CAUSED THE SERIOUS ADVERSE EVENTS. FURTHERMORE, THERE WAS NO REPORT A FRESENIUS PRODUCT AND/OR DEVICE FAILED TO MEET THE USERS¿ EXPECTATIONS AND/OR THE MANUFACTURERS¿ SPECIFICATIONS DURING POST-EVENT FUNCTIONAL COMPLIANCE TESTING. THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

    Description of Event or Problem · 0

    ON 25/MAR/2025, FRESENIUS BECAME AWARE THIS FEMALE PATIENT WITH RENAL FAILURE (RF) ON HEMODIALYSIS (HD) UTILIZING A 2008K2 HEMODIALYSIS SYSTEM FOR RENAL REPLACEMENT THERAPY (RRT) ENCOUNTERED A MEDICAL EVENT DURING HD THERAPY ON (B)(6) 2025, WHICH REQUIRED A ¿RAPID RESPONSE¿ CALL FOR ADDITIONAL MEDICAL STAFF. DURING FOLLOW-UP, THE INPATIENT CHARGE NURSE (ICN) ON (B)(6) 2025, REPORTED THE RAPID RESPONSE CALL WAS NOT DUE TO A CARDIOPULMONARY ARREST, BUT RATHER A LOSS OF CONSCIOUSNESS DUE TO AN EPISODE OF INTRADIALYTIC HYPOTENSION (SPECIFICS NOT PROVIDED). THE PATIENT WAS PLACED ON AN INTRAVENOUS (IV) VASOPRESSOR (DRUG, DOSE, DURATION, FREQUENCY NOT PROVIDED) FOR BLOOD PRESSURE SUPPORT, AND DIALYSIS WAS DISCONTINUED FOR THE REMAINDER OF THE DAY. THE PATIENT STABILIZED AFTER THE SERIOUS ADVERSE EVENTS AND RESUMED HD THERAPY THE FOLLOWING DAY. AS OF (B)(6) 2025, THE PATIENT REMAINS HOSPITALIZED, HOWEVER HER CURRENT DISPOSITION WAS NOT PROVIDED. THE 2008K HEMODIALYSIS SYSTEM WAS SEQUESTERED FOLLOWING THE SERIOUS ADVERSE EVENTS. ON 28/MAR/2025, A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS DISPATCHED TO PERFORM POST-EVENT FUNCTIONAL COMPLIANCE TESTING. THE DEVICE PASSED ALL FUNCTIONAL COMPLIANCE TESTING (E.G., SELF-TESTS, CONDUCTIVITY, TEMPERATURE, PH, ULTRAFILTRATION PUMP), DESPITE ENCOUNTERING A LEAK DURING THE DISINFECTION/RINSE CYCLE (REPAIRED TUBING CONNECTION AT THE UF SAMPLE PORT). FOLLOWING THE REPAIR, THE 2008K2 HEMODIALYSIS SYSTEM DID NOT REQUIRE ANY FURTHER REPAIR OR CALIBRATION AND WAS RETURNED TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264132 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI ERIKA DE REYNOSA, S.A. DE C.V. 00840861100859

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H| L