BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2008T HD SYS. CDX BLUE STAR

    MDR report key: 25325598 · Received May 28, 2026

    Report

    Report Number
    0008030665-2026-01063
    Event Type
    Injury
    Date Received
    May 28, 2026
    Date of Event
    May 7, 2026
    Report Date
    May 28, 2026
    Manufacturer
    ERIKA DE REYNOSA, S.A. DE C.V.
    Product Code
    KDI
    UDI-DI
    00840861102082
    PMA / PMN Number
    K243237
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY. CLINICAL INVESTIGATION: A TEMPORAL RELATIONSHIP EXISTS BETWEEN HD THERAPY UTILIZING A 2008T HD MACHINE AND THE SERIOUS ADVERSE EVENT OF A CARDIAC ARREST, AS THE PATIENT WAS ACTIVELY UNDERGOING HD THERAPY WHEN THE CARDIAC ARREST OCCURRED. THE DEFINITIVE CAUSE OF THE SERIOUS ADVERSE EVENTS WAS NOT PROVIDED; THEREFORE, CAUSALITY COULD NOT BE ESTABLISHED. HOWEVER, PER THE ICN, THE SERIOUS ADVERSE EVENTS WERE UNRELATED TO ANY FRESENIUS DEVICE AND/OR PRODUCT MALFUNCTION OR DEFICIENCY. IT SHOULD BE NOTED THAT A LACK OF ADDITIONAL CLINICAL INFORMATION PRECLUDED A MORE COMPREHENSIVE INVESTIGATION. BASED ON THE INFORMATION AVAILABLE, THE 2008T HD MACHINE CAN BE DISASSOCIATED FROM THE SERIOUS ADVERSE EVENTS. THERE WAS NO ALLEGATION OR OBJECTIVE EVIDENCE INDICATING A FRESENIUS DEVICE(S) AND/OR PRODUCT(S) CAUSED OR CONTRIBUTED TO THE SERIOUS ADVERSE EVENTS. FURTHERMORE, THERE WAS NO REPORT A FRESENIUS PRODUCT(S) AND/OR DEVICE(S) FAILED TO MEET THE USERS¿ EXPECTATIONS, AND POST-EVENT TESTING DID NOT REVEAL ANY DEVICE ISSUES WHICH WOULD HAVE ADVERSELY AFFECTED ITS OPERATION.

    Description of Event or Problem · 0

    A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SUPPORT (TS) THAT A HEMODIALYSIS (HD) PATIENT SUFFERED A CARDIAC ARREST WHILE UNDERGOING HD THERAPY ON A 2008T HD MACHINE. FOLLOW-UP WITH THE INPATIENT CHARGE NURSE (ICN) REVEALED THE PATIENT SUFFERED A CARDIAC ARREST WHILE UNDERGOING HD ON (B)(6) 2026. THE ICN REPORTED HD WAS IMMEDIATELY TERMINATED AND CARDIOPULMONARY RESUSCITATIVE (CPR) MEASURES WERE PERFORMED. THE PATIENT WAS SUCCESSFULLY REVIVED AND THEY WERE TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) FOLLOWING THE SERIOUS ADVERSE EVENTS. THE PATIENT REMAINED IN THE ICU AT THE TIME OF FOLLOW-UP AND WAS UNDERGOING HD WITHOUT ANY KNOWN ISSUES. PER THE ICN, THE HD MACHINE WAS PULLED FROM SERVICE DUE TO POLICY AND PROCEDURE FOLLOWING A CODE SITUATION, AND NOT BECAUSE A FRESENIUS DEVICE DEFICIENCY OR MALFUNCTION WAS SUSPECTED. THE HD MACHINE WAS FIRST EVALUATED BY THE BIOMED AND FUNCTIONED AS EXPECTED. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS DISPATCHED TO PERFORM POST-EVENT FUNCTIONAL COMPLIANCE TESTING ON 8/MAY/2026. THE 2008T HD MACHINE PASSED ALL FUNCTIONAL COMPLIANCE CHECKS AND WAS RETURNED TO SERVICE THAT SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561521 2008T HD SYS. CDX BLUE STAR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI ERIKA DE REYNOSA, S.A. DE C.V. 00840861102082

    Patients

    Seq Age Sex Outcome Treatment
    1