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

Catalog Number	191126
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	01/19/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
Additional information: d9.
Event or Problem Description
The biomedical technician (biomed) reported to fresenius technical services that a hemodialysis patient was in treatment on (b)(6) 2026 utilizing the fresenius 2008t hemodialysis machine when they became restless.The patient was laid flat.The patient relieved themselves during the treatment and the staff proceeded to clean the patient.The patient then complained and wanted to sit up.The patient stopped talking/responding and then coded.Resuscitation was unsuccessful.No alarms or issues with the 2008t machine were noted during treatment.It was requested that the device be inspected.Attempts to obtain additional information were unsuccessful.No further details could be gathered.
Additional Manufacturer Narrative
Clinical review: there is a temporal relationship between hd therapy utilizing the fresenius 2008t hemodialysis machine and the patient event of cardiac arrest and death.However, there is no documentation to show a causal relationship between the adverse event and use of the 2008t machine.Additionally, there is no allegation of a machine malfunction or deficiency reported for this event.The patient became restless prior to the event and then became incontinent during the treatment which are both abnormal indications of an underlying health issue and could be an indication of the impending cardiac event.Although the cause of death was not obtained, ¿cardiac arrest accounts for a quarter of deaths among patients on dialysis.¿ based on the available information and no allegation or evidence of a malfunction or deficiency, the fresenius 2008t hemodialysis machine can be excluded as the cause of the patient¿s cardiac arrest with subsequent death.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
The biomedical technician (biomed) reported to fresenius technical services that a hemodialysis patient was in treatment on (b)(6) 2026 utilizing the fresenius 2008t hemodialysis machine when they became restless.The patient was laid flat.The patient relieved themselves during the treatment and the staff proceeded to clean the patient.The patient then complained and wanted to sit up.The patient stopped talking/responding and then coded.Resuscitation was unsuccessful.No alarms or issues with the 2008t machine were noted during treatment.It was requested that the device be inspected.Attempts to obtain additional information were unsuccessful.No further details could be gathered.
Event or Problem Description
The biomedical technician (biomed) reported to fresenius technical services that a hemodialysis patient was in treatment on (b)(6) 2026 utilizing the fresenius 2008t hemodialysis machine when they became restless.The patient was laid flat.The patient relieved themselves during the treatment and the staff proceeded to clean the patient.The patient then complained and wanted to sit up.The patient stopped talking/responding and then coded.Resuscitation was unsuccessful.No alarms or issues with the 2008t machine were noted during treatment.It was requested that the device be inspected.Attempts to obtain additional information were unsuccessful.No further details could be gathered.
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.However, an on-site evaluation was performed by a fresenius field service technician (fst).Per the fst service report, the machine passed all functional testing and ran without issue.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.Upon completion of the evaluation, there were no malfunctions that could have caused or contributed to the reported event.

• Brand Name: 2008T HD SYS. 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: 24277493
• Report Number: 0008030665-2026-00254
• Device Sequence Number: 15533410
• Product Code: KDI
• UDI-Device Identifier: 00840861102099
• UDI-Public: 00840861102099
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 07/01/2026

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: 191126
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: 02/06/2026; 06/30/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 02/11/2026; 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2025
• 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; Required Intervention
• Patient Sex: Unknown