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	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A user facility biomedical technician (biomed) reported finding thermal damage on the functional board of a fresenius 2008t machine.There was no patient involvement associated with the reported event.The biomed said the machine powered off as the staff began setting up the machines for the day.The machine was removed from service for evaluation.The biomed initially thought there was an issue with the power supply, and they attempted to resolve the issue by replacing the power logic board.After doing so, they were able to power up the machine.However, the clic device was not verifying in dialysis mode.In addition, the keyboard keys were not working.Upon further investigation the biomed found a burnt spot on the functional board.The biomed confirmed that no additional parts or components were damaged.It was confirmed that the functional board was the original fresenius part on the machine.There was no burning smell noticed.Additionally, there were no signs of any smoke, sparks, or flames.There were 15,620 operating hours on the machine.The biomed confirmed machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet and had no previous history of failing the electrical leakage test.The machine remained out of service at the time of follow-up.The biomed ordered a new functional board and was waiting on the part to arrive.The biomed agreed to return the damaged functional board for evaluation.A photo of the board was provided for review.
Additional Manufacturer Narrative
Additional information: h3 plant investigation: although a sample was reported to be available for manufacturer evaluation, to date no parts have been received.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).However, a photograph of the functional board was provided for review and thermal damage is visible on the printed circuit board (pcb) and inductor l16.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 has been confirmed.
Event or Problem Description
A user facility biomedical technician (biomed) reported finding thermal damage on the functional board of a fresenius 2008t machine.There was no patient involvement associated with the reported event.The biomed said the machine powered off as the staff began setting up the machines for the day.The machine was removed from service for evaluation.The biomed initially thought there was an issue with the power supply, and they attempted to resolve the issue by replacing the power logic board.After doing so, they were able to power up the machine.However, the clic device was not verifying in dialysis mode.In addition, the keyboard keys were not working.Upon further investigation the biomed found a burnt spot on the functional board.The biomed confirmed that no additional parts or components were damaged.It was confirmed that the functional board was the original fresenius part on the machine.There was no burning smell noticed.Additionally, there were no signs of any smoke, sparks, or flames.There were 15,620 operating hours on the machine.The biomed confirmed machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet and had no previous history of failing the electrical leakage test.The machine remained out of service at the time of follow-up.The biomed ordered a new functional board and was waiting on the part to arrive.The biomed agreed to return the damaged functional board for evaluation.A photo of the board was provided for review.

• 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: 23103106
• Report Number: 0008030665-2025-02246
• Device Sequence Number: 7394513
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 04/01/2026

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: 190713
• 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: 08/29/2025
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2018
• 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