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); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/03/2026
Type of Reportable Event	Death
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 facility biomedical (biomed) technician reported that a hemodialysis (hd) patient was in treatment utilizing the fresenius 2008t hd machine when they coded.The biomed was requesting an onsite machine evaluation.Additional information documented that this male patient had been admitted to the hospital on (b)(6) 2026 for an internal bleed after a fall.The fall was not related to dialysis.The patient was in hd treatment on (b)(6) 2026 connected to the 2008t machine when his condition was declining rapidly (no specific information provided).The treatment was stopped and the patient was rinsed back.The patient was removed from the machine to attempt to increase his blood pressure.Approximately 30 minutes after being removed from the machine, the patient was pronounced deceased.No additional details were available pertaining to medical interventions or if any resuscitative efforts were administered.The death was determined to be related to the internal bleed from the fall.The request to have the machine evaluated was per their procedure.No issues were found with the machine, and the machine was placed back into service.
Event or Problem Description
A facility biomedical (biomed) technician reported that a hemodialysis (hd) patient was in treatment utilizing the fresenius 2008t hd machine when they coded.The biomed was requesting an onsite machine evaluation.Additional information documented that this male patient had been admitted to the hospital on (b)(6) 2026 for an internal bleed after a fall.The fall was not related to dialysis.The patient was in hd treatment on (b)(6) 2026 connected to the 2008t machine when his condition was declining rapidly (no specific information provided).The treatment was stopped and the patient was rinsed back.The patient was removed from the machine to attempt to increase his blood pressure.Approximately 30 minutes after being removed from the machine, the patient was pronounced deceased.No additional details were available pertaining to medical interventions or if any resuscitative efforts were administered.The death was determined to be related to the internal bleed from the fall.The request to have the machine evaluated was per their procedure.No issues were found with the machine, and the machine was placed back into service.
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation and an on-site evaluation was not performed by a fresenius field service technician (fst).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-conformances, 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 reported event was not confirmed.
Event or Problem Description
A facility biomedical (biomed) technician reported that a hemodialysis (hd) patient was in treatment utilizing the fresenius 2008t hd machine when they coded.The biomed was requesting an onsite machine evaluation.Additional information documented that this male patient had been admitted to the hospital on (b)(6) 2026 for an internal bleed after a fall.The fall was not related to dialysis.The patient was in hd treatment on (b)(6) 2026 connected to the 2008t machine when his condition was declining rapidly (no specific information provided).The treatment was stopped and the patient was rinsed back.The patient was removed from the machine to attempt to increase his blood pressure.Approximately 30 minutes after being removed from the machine, the patient was pronounced deceased.No additional details were available pertaining to medical interventions or if any resuscitative efforts were administered.The death was determined to be related to the internal bleed from the fall.The request to have the machine evaluated was per their procedure.No issues were found with the machine, and the machine was placed back into service.

• 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 ; 6174175172
• MDR Report Key: 24315983
• Report Number: 0008030665-2026-00288
• Device Sequence Number: 17561854
• Product Code: KDI
• UDI-Device Identifier: 00840861102112
• UDI-Public: 00840861102112
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K173972
• 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): 04/01/2026

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: 191130
• 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: 02/03/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2025
• 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: Death
• Patient Sex: Male