MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. 2008T HEMODIALYSIS SYSTEM W/BIBAG; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Catalog Number	190766
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Heart Failure/Congestive Heart Failure (4446)
Date of Event	02/27/2026
Type of Reportable Event	Death
Event or Problem Description
A user facility nurse manager reported to fresenius technical support that a hemodialysis (hd) patient coded while on a fresenius 2008t machine.The nurse manager was requesting for the machine to be validated.Additional information about the event was obtained through follow-up with the nurse manager.It was reported that this patient had pre-existing comorbid conditions of end stage renal disease (esrd), prostate cancer, cardiovascular disease, heart failure with ejection fraction 35%, and non-st elevation myocardial infarction (nstemi).The patient was receiving hd via the fresenius 2008t machine while admitted into the hospital on a cardiac floor.It was reported the patient was in the hospital due to having had a new non-st elevation myocardial infarction (nstemi) with pre-existing heart failure (with a reported ejection fraction of 35%).It was confirmed with the nurse manager that the nstemi was unrelated to dialysis.The nurse manager stated there were no issues with the hd machine related to this event.It was stated that the fresenius hd machine passed all pre-treatment safety checks.Additionally, it was reported that the patient¿s pre-treatment vital signs included a blood pressure (bp) of 105/46 and pulse 92 (within normal limits).The nurse manager indicated that the patient completed the hd treatment and that there were no issues with the treatment.The patient reportedly maintained stable vital signs throughout dialysis with a last recorded bp of 116/46 and pulse 92.Per the nurse manager, upon reinfusion of the patient¿s blood (from the dialysis circuit) the patient became unresponsive.It was reported that the patient had a do not resuscitate (dnr)/do not intubate (dni) status upon hospital admission.Therefore, the patient did not receive resuscitation and expired.Due to hospital policy, the fresenius 2008t machine was pulled from service and evaluated post event.According to the quality record, the machine passed all functional testing (including alarm and pressure holding) with all readings for conductivity, ph and temperature verified via independent meter.Furthermore, the nurse manager reported the machine passed all post event testing and stated that the machine was returned to service without any issues.The nurse manager stated there is no allegation that the fresenius machine caused the patient¿s death.It was provided that the patient expired from sudden cardiac arrest due to pre-existing comorbid conditions of heart failure and new nstemi.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: a temporal relationship exists between hemodialysis treatment via a fresenius 2008t machine and the event of patient sudden cardiac arrest with death.Hemodialysis patients have a higher rate of cardiovascular morbidity and mortality than the general population.At the time of this clinical investigation, there has been no allegation that the death was caused by product.Additionally, there is no documentation in the quality record that the fresenius 2008t machine had a malfunction or product deficiency.The patient had comorbid conditions of end-stage renal disease (esrd), heart failure (with ejection fraction 35%), and new non-st elevation myocardial infarction (nstemi).Additionally, the patient had a dnr/dni order.Therefore, the patient¿s death is very likely to be attributed to patient pre-existing comorbid conditions without resuscitation for sudden cardiac arrest.
Additional Manufacturer Narrative
Additional information: h3 plant investigation: no parts were returned to the manufacturer for physical evaluation.However, a fresenius field service technician (fst) was dispatched to the facility to perform post-event functional testing on the machine.The device passed all functional testing.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.There were no reported issues found during functional testing of the machine, and thus the complaint could not be confirmed.
Event or Problem Description
A user facility nurse manager reported to fresenius technical support that a hemodialysis (hd) patient coded while on a fresenius 2008t machine.The nurse manager was requesting for the machine to be validated.Additional information about the event was obtained through follow-up with the nurse manager.It was reported that this patient had pre-existing comorbid conditions of end stage renal disease (esrd), prostate cancer, cardiovascular disease, heart failure with ejection fraction 35%, and non-st elevation myocardial infarction (nstemi).The patient was receiving hd via the fresenius 2008t machine while admitted into the hospital on a cardiac floor.It was reported the patient was in the hospital due to having had a new non-st elevation myocardial infarction (nstemi) with pre-existing heart failure (with a reported ejection fraction of 35%).It was confirmed with the nurse manager that the nstemi was unrelated to dialysis.The nurse manager stated there were no issues with the hd machine related to this event.It was stated that the fresenius hd machine passed all pre-treatment safety checks.Additionally, it was reported that the patient¿s pre-treatment vital signs included a blood pressure (bp) of 105/46 and pulse 92 (within normal limits).The nurse manager indicated that the patient completed the hd treatment and that there were no issues with the treatment.The patient reportedly maintained stable vital signs throughout dialysis with a last recorded bp of 116/46 and pulse 92.Per the nurse manager, upon reinfusion of the patient¿s blood (from the dialysis circuit) the patient became unresponsive.It was reported that the patient had a do not resuscitate (dnr)/do not intubate (dni) status upon hospital admission.Therefore, the patient did not receive resuscitation and expired.Due to hospital policy, the fresenius 2008t machine was pulled from service and evaluated post event.According to the quality record, the machine passed all functional testing (including alarm and pressure holding) with all readings for conductivity, ph and temperature verified via independent meter.Furthermore, the nurse manager reported the machine passed all post event testing and stated that the machine was returned to service without any issues.The nurse manager stated there is no allegation that the fresenius machine caused the patient¿s death.It was provided that the patient expired from sudden cardiac arrest due to pre-existing comorbid conditions of heart failure and new nstemi.

• Brand Name: 2008T HEMODIALYSIS SYSTEM W/BIBAG
• Common Device Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; director, quality systems; 900 w zaragosa drive suite d; pharr TX 78577
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; +1(617)417-5172
• MDR Report Key: 24706872
• Report Number: 0008030665-2026-00580
• Device Sequence Number: 21442409
• Product Code: KDI
• UDI-Device Identifier: 00840861100910
• UDI-Public: 00840861100910
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K150708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 190766
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2026
• Supplement Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 67 YR
• Patient Sex: Male