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

Catalog Number	191130
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914)
Date of Event	04/11/2026
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 with the fresenius 2008 t machine and the patient event of hypotension.Hypotension is a common complication during hemodialysis treatment.It was reported that the patient¿s hemodialyis treatment ended due to hypotension and that the patient coded approximately 15 minutes later.Hypotension during hemodialysis can lead to many adverse effects and potential life-threatening complications.With the limited information available, it cannot be determined what exactly caused this event.Currently, there is no reported issues with the fresenius 2008 t machine during the patient¿s treatment.Additionally, there is no allegation by the user facility that the 2008 t machine caused this event to occur.However, the device had a ultrafiltration pump error of 10ml during post event evaluation.It cannot be determined if this ultrafiltration pump error caused the machine to malfunction and cause a serious injury to the patient.However, given all the information available the 2008 t machine cannot be excluded as possible contributory factor.
Event or Problem Description
On 13/apr/2026, it was reported that this patient experienced decreased blood pressure approximately 30 minutes into a hemodialysis treatment utilizing the fresenius 2008 t machine (serial number (b)(6)).The patient¿s treatment was ended.Subsequently, approximately 15 minutes later the patient coded after being transported to a hospital room.There were no reported allegations of any issues with the operation of the fresenius 2008 t machine.In additional follow-up, the biomedical technician associated with the user facility confirmed that the patient¿s treatment was ended due to low blood pressure during hemodialysis treatment on (b)(6) 2026.Additionally, it was confirmed that the patient was not on the fresenius hemodialysis machine when the code occurred.The biomedical technician had no other information about the patient available and could not provide medical contact to follow up with.However, the biomedical technician stated that there is no allegation against the fresenius 2008 t machine nor any suspicion that the machine caused this event.The biomedical technician requested to have the machine evaluated (post event) by hospital policy.Contained in the file is the post event testing of the fresenius 2008 t machine (serial number (b)(6)) on (b)(6) 2026.It was documented that the machine passed self-test prior to the event.The machine passed all testing except the tcd conductivity test.However, all conductivity readings documented were documented within the normal limits.Additionally, in the ultrafiltration problem identification checklist it was documented that there was an ultrafiltration pump error by 10ml.It is unknown if this failure caused or contributed to the patient event.

• Brand Name: 2008T HD SYS. W/O CDX W/BIBAG 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: 25002171
• Report Number: 0008030665-2026-00806
• Device Sequence Number: 9773631
• Product Code: KDI
• UDI-Device Identifier: 00840861102112
• UDI-Public: 00840861102112
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2026

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: Other
• Device Catalogue Number: 191130
• Was Device Available for Evaluation?: No
• 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: 04/13/2026
• Supplement Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 04/27/2026
• Supplement Report FDA Received Date: 08/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS BLOODLINES; FRESENIUS DIALYZER
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Unknown