MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. 2008T HEMODIALYSIS SYS., WITH CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	190713
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	10/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Plant investigation: 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 the 2008t hemodialysis system, and the serious adverse event of cardiac arrest.The etiology of the serious adverse event remains unknown; therefore, causality could not be firmly established.However, the pre-service evaluation, post-event functional compliance testing and uf testing following the serious adverse event, determined the 2008t hemodialysis system was functioning as intended.It should be noted that the lack of clinical follow-up precluded a more comprehensive investigation.Based on the information available, the 2008t hemodialysis system can be disassociated from the serious adverse events.There is no allegation or objective evidence indicating a fresenius device and/or product caused the serious adverse events.Furthermore, there was no report a fresenius product and/or device failed to meet the users¿ expectations and/or the manufacturers¿ specifications during post-event functional compliance testing.
Event or Problem Description
On 2/oct/2025, fresenius became aware this unknown patient with renal failure (rf) on hemodialysis (hd) utilizing a 2008t hemodialysis system for renal replacement therapy (rrt) ¿coded¿ (cardiac arrest) while undergoing hd therapy.The user facility contacted fresenius customer support to request and evaluation of the device.On (b)(6) 2025, a fresenius field service technician (fst) was dispatched to perform post-event functional compliance and ultrafiltration (uf) testing on the 2008t hemodialysis system.All post-event testing was completed and passed without issue.There were no values out-of-range, nor were there any errors noted while performing a simulated treatment.Subsequent attempts to obtain additional clinical information (e.G., patient demographics, outcome of code event(s), past medical history, hospital course) were unsuccessful.
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.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-conformance's, 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.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
Event or Problem Description
On 2/oct/2025, fresenius became aware this unknown patient with renal failure (rf) on hemodialysis (hd) utilizing a 2008t hemodialysis system for renal replacement therapy (rrt) ¿coded¿ (cardiac arrest) while undergoing hd therapy.The user facility contacted fresenius customer support to request and evaluation of the device.On 15/oct/2025, a fresenius field service technician (fst) was dispatched to perform post-event functional compliance and ultrafiltration (uf) testing on the 2008t hemodialysis system.All post-event testing was completed and passed without issue.There were no values out-of-range, nor were there any errors noted while performing a simulated treatment.Subsequent attempts to obtain additional clinical information (e.G., patient demographics, outcome of code event(s), past medical history, hospital course) were unsuccessful.

• Brand Name: 2008T HEMODIALYSIS SYS., WITH 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 ; 6174175172
• MDR Report Key: 23349498
• Report Number: 0008030665-2025-02520
• Device Sequence Number: 15396306
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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: Other
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2019
• 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: Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Unknown