BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2008T MACHINE

    MDR report key: 21816391 · Received April 10, 2025

    Report

    Report Number
    0008030665-2025-00829
    Event Type
    Injury
    Date Received
    April 10, 2025
    Date of Event
    March 20, 2025
    Report Date
    April 10, 2025
    Manufacturer
    ERIKA DE REYNOSA, S.A. DE C.V.
    Product Code
    KDI
    PMA / PMN Number
    K150708
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLANT INVESTIGATION: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND THE SERIAL NUMBER COULD NOT BE OBTAINED. ADDITIONALLY, NO ON-SITE EVALUATION WAS PERFORMED BY A FRESENIUS FIELD SERVICE TECHNICIAN (FST). AS A SERIAL NUMBER COULD NOT BE DETERMINED, DEVICE HISTORY AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. AS A PHYSICAL EVALUATION COULD NOT BE PERFORMED, A DEFINITIVE CONCLUSION REGARDING THE REPORTED INCIDENT COULD NOT BE REACHED AND A CAUSE COULD NOT BE CONFIRMED. THE COMPLAINT INVESTIGATION DID NOT FIND OBJECTIVE EVIDENCE INDICATING A PRODUCT PROBLEM, AND THUS THE COMPLAINT WAS NOT CONFIRMED. CLINICAL INVESTIGATION: A TEMPORAL RELATIONSHIP EXISTS BETWEEN HD THERAPY UTILIZING A 2008T MACHINE AND THE SERIOUS ADVERSE EVENT OF A CARDIOPULMONARY ARREST, AS THE PATIENT WAS UNDERGOING HD THERAPY WHEN THE SERIOUS ADVERSE EVENT OCCURRED. THE ICN ATTRIBUTED CAUSALITY TO ASPIRATION PNEUMONIA, DUE TO THE PATIENT ASPIRATING THEIR TUBE FEEDING. IT SHOULD BE NOTED THAT A LACK OF CLINICAL FOLLOW-UP INFORMATION PRECLUDED A MORE COMPREHENSIVE INVESTIGATION. HOWEVER, PATIENTS UNDERGOING DIALYSIS HAVE A 10 TO 20 TIMES HIGHER RISK OF SUDDEN CARDIAC ARREST (SCA) THAN THE GENERAL POPULATION. PER THE ICN, THE SERIOUS ADVERSE EVENT WAS UNRELATED TO ANY FRESENIUS PRODUCT(S) AND/OR DEVICE(S) DEFICIENCY OR MALFUNCTION. BASED ON THE INFORMATION AVAILABLE, THE PATIENT'S 2008T HD MACHINE 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 OR CONTRIBUTED TO THE SERIOUS ADVERSE EVENTS. FURTHERMORE, THERE WAS NO REPORT A FRESENIUS DEVICE(S) AND/OR PRODUCT(S) FAILED TO MEET THE USERS¿ EXPECTATIONS AND/OR THE MANUFACTURERS¿ SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO FRESENIUS THAT A HEMODIALYSIS (HD) PATIENT UTILIZING A 2008T MACHINE CODED (CARDIOPULMONARY ARREST) DURING HD THERAPY. FOLLOW-UP WITH THE PATIENT¿S INPATIENT CHARGE NURSE (ICN) REVEALED THE PATIENT SURVIVED THE CODE AND WAS TRANSFERRED TO THE MEDICAL INTENSIVE CARE UNIT (MICU) POST-EVENT, WHERE THE PATIENT WAS INTUBATED AND STILL RESIDES. THE ICN STATED THE PATIENT'S CARDIOPULMONARY ARREST WAS ATTRIBUTED TO AN OCCURRENCE OF ASPIRATION PNEUMONIA, DUE TO THE PATIENT'S ASPIRATING TUBE FEEDING (TIMELINE NOT PROVIDED). ALTHOUGH THE ICN COULD NOT PROVIDE ADDITIONAL CLINICAL INFORMATION, THEY REPORTED THE 2008T MACHINE PASSED ALL POST-EVENT FUNCTIONAL COMPLIANCE TESTING AND WAS RETURNED TO SERVICE. PER THE ICN, THE EVENTS WERE UNRELATED TO ANY FRESENIUS PRODUCT(S) AND/OR DEVICE(S) DEFICIENCY OR MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383751 2008T MACHINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI ERIKA DE REYNOSA, S.A. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R