MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. 2008T HEMODIALYSIS SYSTEM W/BIBAG; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Catalog Number	190766
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility biomedical technician (biomed) reported to fresenius technical support (ts) that a 2008t hemodialysis machine was experiencing an issue with its display screen.The biomed stated the screen was black.The biomed said they had already replaced the ui mics board, the ui to function board ribbon cable, and the screen.Ts advised the biomed to check the motherboard and all wired connections and connectors.Additional details were provided during follow-up with the biomed.Upon further investigation, the biomed identified thermal damage on the connector of the ground wire that goes from the power module to the main distribution board.The biomed replaced the whole power module (which included a new ground wire and connector), and this resolved the reported screen issue.No other components were found to be damaged.The distribution board did not have to be replaced.The biomed did not have any photos of the charred wire/connector.There was no burning smell noted, and there were no signs of any smoke, sparks, or flames.The biomed said the machine had 43,487 operating hours on it at the time of the event.The machine did not have any past problems failing the electrical leakage test, and it was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The biomed confirmed the machine was back in service and fully operational.There was no patient involvement associated with this event.The replaced parts were not available to be sent back for evaluation.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

• Brand Name: 2008T HEMODIALYSIS SYSTEM W/BIBAG
• 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: 50202782
• Report Number: 0008030665-2026-02158
• Device Sequence Number: 5496559
• Product Code: KDI
• UDI-Device Identifier: 00840861100910
• UDI-Public: 00840861100910
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K231125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 190766
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2026
• Supplement Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 08/11/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2016
• 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
• Patient Sex: Unknown