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 Codes	Thermal Decomposition of Device (1071); Arcing (2583); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
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 that a fresenius 2008t hemodialysis (hd) machine produced an electric arc which came from the power supply.The biomed said the machine was initially pulled from the treatment floor for failing an unknown test during set-up.There was no patient involvement associated with the event.When the machine was turned on for testing, a spark (or arc) was observed coming from the power supply.The machine was immediately turned off and unplugged.Upon further inspection, a burnt wire was identified on the back of the power supply board.The biomed said the wire looked scorched or blackened.A burnt electrical smell was also reported to be present.No other components were found to be damaged.It is believed that the power supply was the original fresenius part that came with the system.The biomed replaced the power supply unit and this reportedly resolved the issue.The machine subsequently passed testing and was returned to service.The biomed stated the machine had 45,384 operating hours on it.It was confirmed the 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 faulty power supply was sent back for evaluation, and a photo of the damage was provided for review.
Event or Problem Description
A user facility biomedical technician (biomed) reported that a fresenius 2008t hemodialysis (hd) machine produced an electric arc which came from the power supply.The biomed said the machine was initially pulled from the treatment floor for failing an unknown test during set-up.There was no patient involvement associated with the event.When the machine was turned on for testing, a spark (or arc) was observed coming from the power supply.The machine was immediately turned off and unplugged.Upon further inspection, a burnt wire was identified on the back of the power supply board.The biomed said the wire looked scorched or blackened.A burnt electrical smell was also reported to be present.No other components were found to be damaged.It is believed that the power supply was the original fresenius part that came with the system.The biomed replaced the power supply unit and this reportedly resolved the issue.The machine subsequently passed testing and was returned to service.The biomed stated the machine had 45,384 operating hours on it.It was confirmed the 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 faulty power supply was sent back for evaluation, and a photo of the damage 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 sample was provided for review.In the provided photo, thermal decomposition was observed on the wires.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 confirmed by referencing the provided photo.

• 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: 24242559
• Report Number: 0008030665-2026-00215
• Device Sequence Number: 9971279
• 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,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2026

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: 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: 01/09/2026
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2012
• 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