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	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
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's biomedical technician (bmt) reported that a 2008t hemodialysis (hd) machine experienced a fire during a patient's hd treatment.Upon follow up, the bmt said that the fire originated in the power supply.The cause of the fire was unknown; however, there was a burning smell as well as visible smoke and flames.The bmt confirmed that the machine has approximately 29,953 hours and is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The machine has not had any past problems with failing the electrical leakage test.The power supply was the original fresenius part on the machine.There was no damage to any other components due to the event.There was no harm to any patients or individuals because of this event.The patient was restarted on a new machine and treatment completed successfully with new supplies.There was no patient serious injury or medical intervention required as a result of this event.The patient¿s blood was not returned following the event.The patient¿s estimated blood loss (ebl) is unknown.A fresenius field service technician (fst) was called onsite and they replaced the power supply to resolve the issue.No other issues were noted.Machine functional tests were completed and passed onsite after repair.The complaint device was returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Additional information: d9, h3.Plant investigation: no parts were returned to the manufacturer for physical evaluation and an on-site evaluation was not performed by a fresenius field service technician (fst).The manufacturer was able to determine a causal relationship between the objective evidence provided by the customer and the reported event.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's biomedical technician (bmt) reported that a 2008t hemodialysis (hd) machine experienced a fire during a patient's hd treatment.Upon follow up, the bmt said that the fire originated in the power supply.The cause of the fire was unknown however, there was a burning smell as well as visible smoke and flames.The bmt confirmed that the machine has approximately 29,953 hours and is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The machine has not had any past problems with failing the electrical leakage test.The power supply was the original fresenius part on the machine.There was no damage to any other components due to the event.There was no harm to any patients or individuals because of this event.The patient was restarted on a new machine and treatment completed successfully with new supplies.There was no patient serious injury or medical intervention required as a result of this event.The patient¿s blood was not returned following the event.The patient¿s estimated blood loss (ebl) is unknown.A fresenius field service technician (fst) was called onsite and they replaced the power supply to resolve the issue.No other issues were noted.Machine functional tests were completed and passed onsite after repair.The complaint device was returned to the manufacturer for evaluation.

• 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: 24789390
• Report Number: 0008030665-2026-00636
• Device Sequence Number: 15622463
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 07/01/2026

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: 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: 03/10/2026
• Supplement Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2017
• 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