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	02/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility biomedical technician (bmt) reported they were working on a 2008t hemodialysis (hd) machine that had damage to the distribution board and heater rod wiring.One of the wires for the heater rod arced.The bmt replaced the distribution board and heater rod.The bmt stated they were having to set the digital-to-analog converter (dac) value up to 160-165 to achieve 37 degrees celsius and asked if this was normal.The bmt was advised the dav value range was 0-255.Upon follow-up, the bmt stated during troubleshooting of calibrating dac values it was discovered the distribution board and heater rod wiring appeared arced and burnt.The bmt replaced the distribution board and heater rod wiring and this resolved the issue.No smoke or melting was noted, and there were no reports of sparks or flames.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet, and there was no previous history of the machine failing the electrical leakage test.The bmt stated the machine was repaired but has not yet been returned to service.The replaced parts were no longer available to be returned for evaluation.There was no patient involvement associated with the reported event.
Additional Manufacturer Narrative
Plant investigation: 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 (bmt) reported they were working on a 2008t hemodialysis (hd) machine that had damage to the distribution board and heater rod wiring.One of the wires for the heater rod arced.The bmt replaced the distribution board and heater rod.The bmt stated they were having to set the digital-to-analog converter (dac) value up to 160-165 to achieve 37 degrees celsius and asked if this was normal.The bmt was advised the dav value range was 0-255.Upon follow-up, the bmt stated during troubleshooting of calibrating dac values it was discovered the distribution board and heater rod wiring appeared arced and burnt.The bmt replaced the distribution board and heater rod wiring and this resolved the issue.No smoke or melting was noted, and there were no reports of sparks or flames.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet, and there was no previous history of the machine failing the electrical leakage test.The bmt stated the machine was repaired but has not yet been returned to service.The replaced parts were no longer available to be returned for evaluation.There was no patient involvement associated with the reported event.
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.Complaint investigation found objective evidence indicating a product problem, thus the complaint is confirmed.Additionally, no on-site evaluation was 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 investigation into the cause of the reported problem was able to be confirmed.

• 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 ; +1(617)417-5172
• MDR Report Key: 24365209
• Report Number: 0008030665-2026-00333
• Device Sequence Number: 9661142
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 09/02/2026

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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Supplement Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2011
• 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