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

Catalog Number	190858
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	08/11/2026
Type of Reportable Event	Death
Event or Problem Description
On (b)(6) 2026 a biomedical technician requested onsite service for machine verification following a hemodialysis (hd) patient incident on the 2008t hemodialysis machine.The patient coded and passed away on the machine.Attempts to obtain additional information were unsuccessful.The fresenius medical care field service technician (fst) evaluated the machine.The fst performed the ultrafiltration (uf) problem identification checklist according to p/n 507162 rev.G, performed uf pump calibration, verified 1.0cc/ml, functional checks were performed, and the machine was heat disinfected.The machine passed all functional testing.No further information was provided.
Additional Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: there is a temporal relationship between hd therapy utilizing the fresenius 2008t hemodialysis machine and the patient event of coding with subsequent death.However, there is no documentation to show a causal relationship between the adverse event and use of the 2008t machine.Additionally, there is no allegation of a machine malfunction or deficiency reported for this event.Although the cause of death was not obtained, ¿cardiac arrest accounts for a quarter of deaths among patients on dialysis.¿ there were no reported issues with the 2008t machine, and the machine passed all functional testing during evaluation.Based on the available information and no allegation or evidence of a malfunction or deficiency, the fresenius 2008t hemodialysis machine can be excluded as the cause of the patient¿s coding and death.

• Brand Name: 2008T HEMODIALYSIS SYSTEM WITHOUT CDX
• 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: 50451622
• Report Number: 0008030665-2026-02285
• Device Sequence Number: 16073984
• Product Code: KDI
• UDI-Device Identifier: 00840861100903
• UDI-Public: 00840861100903
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K231125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 08/25/2026

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: 190858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Fresenius Bloodlines.; Fresenius Dialyzer.
• Outcome Attributed to Adverse Event: Death; Life Threatening
• Patient Sex: Unknown