BEUDAMED
    FDA Adverse Event Death Summary report: N

    2008T HD SYS. W/O CDX W/BIBAG BLUE STAR

    MDR report key: 24443623 · Received February 25, 2026

    Report

    Report Number
    0008030665-2026-00390
    Event Type
    Death
    Date Received
    February 25, 2026
    Date of Event
    February 19, 2026
    Report Date
    April 1, 2026
    Manufacturer
    ERIKA DE REYNOSA, S.A. DE C.V.
    Product Code
    KDI
    UDI-DI
    00840861102112
    PMA / PMN Number
    K173972
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY. CLINICAL REVIEW: A TEMPORAL RELATIONSHIP EXISTS BETWEEN HD THERAPY UTILIZING A 2008T HEMODIALYSIS SYSTEM AND THE SERIOUS ADVERSE EVENT OF A CARDIAC ARREST, AND EVENTUAL DEATH THE FOLLOWING DAY. THE DEFINITIVE ETIOLOGY OF THE SERIOUS ADVERSE EVENTS IS UNKNOWN; THEREFORE, CAUSALITY COULD NOT BE FIRMLY ESTABLISHED. HOWEVER, THE ICN STATED THE PATIENT¿S CONDITION WAS ¿TENUOUS AT BEST¿ PRIOR TO INITIATING HD, AND THE FAMILY UNDERSTOOD ATTEMPTING HD WOULD BE EXTREMELY RISKY. IT SHOULD BE NOTED THAT LIMITED CLINICAL FOLLOW-UP INFORMATION PRECLUDED A MORE COMPREHENSIVE INVESTIGATION. HOWEVER, DURING POST-EVENT TESTING THE 2008T HEMODIALYSIS SYSTEM PASSED ALL FUNCTIONAL COMPLIANCE AND UF TESTING. THE ESRD POPULATION CONTINUES TO HAVE SIGNIFICANTLY HIGHER MORTALITY, AND FEWER EXPECTED YEARS OF LIFE WHEN COMPARED TO THE GENERAL POPULATION. BASED ON THE INFORMATION AVAILABLE, THE 2008T HEMODIALYSIS SYSTEM CAN BE DISASSOCIATED FROM THE SERIOUS ADVERSE EVENTS. THERE IS NO ALLEGATION OR OBJECTIVE EVIDENCE INDICATING A FRESENIUS DEVICE(S) AND/OR PRODUCT(S) CAUSED THE SERIOUS ADVERSE EVENTS. FURTHERMORE, THERE WAS NO REPORT OF A FRESENIUS DEVICE(S) AND/OR PRODUCT(S) FAILING TO MEET THE USERS¿ EXPECTATIONS AND/OR THE MANUFACTURERS¿ SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. A RECORDS REVIEW WAS PERFORMED ON THE REPORTED SERIAL NUMBER. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO NON-CONFORMANCES, OR ANY ASSOCIATED REWORK IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE RELATED TO THE REPORTED EVENT. IN ADDITION, THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE INVESTIGATION INTO THE CAUSE OF THE REPORTED PROBLEM WAS NOT ABLE TO BE CONFIRMED. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS UNKNOWN PATIENT WITH RENAL FAILURE (RF) ON HEMODIALYSIS (HD) UTILIZING A 2008T HEMODIALYSIS SYSTEM FOR RENAL REPLACEMENT THERAPY (RRT) EXPERIENCED A CODE (CARDIAC ARREST) DURING TREATMENT ON (B)(6) 2026. FOLLOW-UP WITH THE INPATIENT CHARGE NURSE (ICN) CONFIRMED A PATIENT CODED WHILE UNDERGOING HEMODIALYSIS (HD) ON (B)(6) 2026 WHILE IN THE INTENSIVE CARE UNIT. THE ICN STATED THE PATIENT¿S CONDITION WAS ¿TENUOUS AT BEST¿ PRIOR TO INITIATING HD, AND THE FAMILY UNDERSTOOD ATTEMPTING HD WOULD BE ¿EXTREMELY RISKY.¿ THE ICN STATED SHE COULD NOT PROVIDE ANY MORE CLINICAL INFORMATION; HOWEVER, SHE REPORTED THE PATIENT PASSED AWAY THE FOLLOWING DAY ON (B)(6) 2026. PER THE ICN, THE SERIOUS ADVERSE EVENTS WERE NOT CAUSED BY ANY FRESENIUS PRODUCT(S), DRUG(S), AND/OR DEVICE(S) DEFICIENCY OR MALFUNCTION. THE 2008T HEMODIALYSIS SYSTEM WAS TAKEN OUT OF SERVICE, AND AN EVALUATION OF THE DEVICE WAS REQUESTED BY THE HOSPITAL. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS DISPATCHED TO PERFORM POST-EVENT FUNCTIONAL COMPLIANCE TESTING ON (B)(6) 2026, AND THE DEVICE PASSED ALL POST-EVENT COMPLIANCE AND ULTRAFILTRATION TESTING. THE ICN CONFIRMED THE 2008T HEMODIALYSIS SYSTEM WAS CLEARED BY THE BIOMEDICAL TECHNICIAN, AFTER WHICH IT WAS DISINFECTED AND RETURNED TO SERVICE. THE ICN REITERATED THE 2008T HEMODIALYSIS MACHINE WAS PULLED FROM SERVICE FOLLOWING THE CARDIAC ARREST DUE TO PROTOCOL, AND NOT DUE TO A SUSPECTED DEVICE ISSUE. DURING POST-EVENT TESTING, IT WAS DISCOVERED THE DEAERATION PRESSURE WAS -25.4 INHG, AND REQUIRED RECALIBRATION TO -24.9 INHG, HOWEVER THIS WOULD NOT HAVE ADVERSELY AFFECTED THE FUNCTIONALITY OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS UNKNOWN PATIENT WITH RENAL FAILURE (RF) ON HEMODIALYSIS (HD) UTILIZING A 2008T HEMODIALYSIS SYSTEM FOR RENAL REPLACEMENT THERAPY (RRT) EXPERIENCED A CODE (CARDIAC ARREST) DURING TREATMENT ON (B)(6) 2026. FOLLOW-UP WITH THE INPATIENT CHARGE NURSE (ICN) CONFIRMED A PATIENT CODED WHILE UNDERGOING HEMODIALYSIS (HD) ON 19/FEB/2026 WHILE IN THE INTENSIVE CARE UNIT. THE ICN STATED THE PATIENT¿S CONDITION WAS ¿TENUOUS AT BEST¿ PRIOR TO INITIATING HD, AND THE FAMILY UNDERSTOOD ATTEMPTING HD WOULD BE ¿EXTREMELY RISKY.¿ THE ICN STATED SHE COULD NOT PROVIDE ANY MORE CLINICAL INFORMATION; HOWEVER, SHE REPORTED THE PATIENT PASSED AWAY THE FOLLOWING DAY ON (B)(6) 2026. PER THE ICN, THE SERIOUS ADVERSE EVENTS WERE NOT CAUSED BY ANY FRESENIUS PRODUCT(S), DRUG(S), AND/OR DEVICE(S) DEFICIENCY OR MALFUNCTION. THE 2008T HEMODIALYSIS SYSTEM WAS TAKEN OUT OF SERVICE, AND AN EVALUATION OF THE DEVICE WAS REQUESTED BY THE HOSPITAL. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS DISPATCHED TO PERFORM POST-EVENT FUNCTIONAL COMPLIANCE TESTING ON (B)(6) 2026, AND THE DEVICE PASSED ALL POST-EVENT COMPLIANCE AND ULTRAFILTRATION TESTING. THE ICN CONFIRMED THE 2008T HEMODIALYSIS SYSTEM WAS CLEARED BY THE BIOMEDICAL TECHNICIAN, AFTER WHICH IT WAS DISINFECTED AND RETURNED TO SERVICE. THE ICN REITERATED THE 2008T HEMODIALYSIS MACHINE WAS PULLED FROM SERVICE FOLLOWING THE CARDIAC ARREST DUE TO PROTOCOL, AND NOT DUE TO A SUSPECTED DEVICE ISSUE. DURING POST-EVENT TESTING, IT WAS DISCOVERED THE DEAERATION PRESSURE WAS -25.4 INHG, AND REQUIRED RECALIBRATION TO -24.9 INHG, HOWEVER THIS WOULD NOT HAVE ADVERSELY AFFECTED THE FUNCTIONALITY OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274854 2008T HD SYS. W/O CDX W/BIBAG BLUE STAR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI ERIKA DE REYNOSA, S.A. DE C.V. 00840861102112

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H| D