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 Code	Insufficient Information (4580)
Date of Event	04/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 hemodialysis utilizing the 2008t hemodialysis machine and the patient experiencing a sentinel event (unspecified).However, there is no documentation in the complaint file to show a causal relationship between the adverse event and use of the 2008t hemodialysis machine.Additionally, there was no allegation of a device malfunction or deficiency for the reported event.The biomed requested that the fst evaluate the device as part of the facility¿s due diligence.The biomed had already conducted evaluation and testing in which the machine passed all tests.Although the fst found the uf balance error to fail in the machine evaluation, it was not confirmed if this had any correlation to the reported patient event.No further information was provided related to the patient event or the patient outcome.Based on the limited information and no allegation or evidence of a malfunction or deficiency, the 2008t hemodialysis machine can be excluded as the cause of the patient¿s sentinel event.
Event or Problem Description
During follow-up for a work order request for a 2008t hemodialysis machine, it was reported that a patient had died.Follow-up was conducted with the biomedical technician (biomed) from the user facility.The biomed stated that there was a sentinel event (unspecified) that occurred with a patient connected to the machine.The patient event was not suspected to be related to any issue with the machine; however, the biomed wanted to do full due diligence and have the machine inspected by a field service technician (fst).The biomed stated they completed their own testing and evaluation after the event, and the machine passed all tests.The biomed stated the patient outcome could not be confirmed.No additional information pertaining to the patient event was available.An fst was subsequently dispatched to the facility to evaluate and test the machine.It was only reported that a patient adverse event occurred and the patient did not complete treatment.During the testing and evaluation, the machine failed to pass the ultrafiltration (uf) balance error.During the 1-hour simulated run, the uf balance error failed.The maximum allowable error is +/- 30ml for a 1-hour simulation and the result was 40ml (fail).A check of the balancing chamber was completed 3 times.The device showed signs of an internal balancing chamber leak.The fst reported that it was possible a balancing chamber valve was leaking internally or a balancing chamber membrane was torn allowing an internal leak.This would explain why the machine failed the uf balance error.The fst recommended that the balancing chamber be replaced and calibrated prior to the machine being put back in service.It was also recommended that the acid and bicarbonate pumps be recalibrated after the chamber replacement.It was not advised that the machine be used on patients until the repairs and calibrations were performed.Based on the information provided by the biomed, it was not suspected that the patient event was related to use of the machine.

• 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: 25308912
• Report Number: 0008030665-2026-01039
• Device Sequence Number: 13238489
• Product Code: KDI
• UDI-Device Identifier: 00840861100910
• UDI-Public: 00840861100910
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

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: 190766
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2026
• Supplement Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 05/27/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2018
• 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: Other; Required Intervention
• Patient Sex: Unknown