MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. 2008T HD SYS. CDX BLUE STAR; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Catalog Number	191124
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	05/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
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 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.

• Brand Name: 2008T HD SYS. CDX BLUE STAR
• 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: 25325598
• Report Number: 0008030665-2026-01063
• Device Sequence Number: 9986109
• Product Code: KDI
• UDI-Device Identifier: 00840861102082
• UDI-Public: 00840861102082
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K243237
• 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,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2026

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: 191124
• 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: 05/07/2026
• Supplement Date Received by Manufacturer: 07/29/2026
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 07/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2024
• 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: Required Intervention; Hospitalization; Life Threatening
• Patient Sex: Unknown