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	10/22/2025
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
The biomedical technician (biomed) for a user facility reported to fresenius technical services that thermal decomposition was identified within the 2008t machine.The reported issue was discovered upon machine evaluation for an intermittent 24v error.The bridge rectifier and the two white wires connected to the transformer were burned.A burning smell was observed however there was no smoke, spark, flame, or arcing.The machine has approximately 30,000 operating hours and the parts are original to the machine.The machine is plugged into a 20-amp hospital-grade ground-fault circuit interrupter (gfci) outlet.A replacement power supply was ordered to resolve the reported issue.At the time of follow-up the machine remained out of service pending repair.There was no harm to any patients or individuals as a result of this malfunction.No parts will be returned to the manufacturer for physical evaluation.
Event or Problem Description
The biomedical technician (biomed) for a user facility reported to fresenius technical services that thermal decomposition was identified within the 2008t machine.The reported issue was discovered upon machine evaluation for an intermittent 24v high error.The bridge rectifier, the two white wires connected to the transformer, and the power cord were burned.A replacement power supply was ordered and installed.A conductivity offset failure alarm was then received.Further evaluation was performed and the cause was determined to be the sensor board.A replacement sensor board was ordered to resolve this issue.At the time of follow-up, the machine remained out of service pending repair.A burning smell was observed however there was no smoke, spark, flame, or arcing.The machine has approximately 30,000 operating hours and the parts are original to the machine.The machine is plugged into a 20-amp hospital-grade ground-fault circuit interrupter (gfci) outlet.There was no harm to any patients or individuals as a result of this malfunction.No parts will be returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Additional information: b5 (event description), h6 (device component code) the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

• 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: 23379802
• Report Number: 0008030665-2025-02549
• Device Sequence Number: 8863565
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2025

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: Health Professional
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2016
• 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