MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. 2008T HD SYS. CDX W/BIBAG BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	191126
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
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 2008t hemodialysis (hd) machine powered down during chemical uptake and a small curl of smoke was emitted from the power supply.Additional details were provided upon follow-up with the biomed.The biomed reported that a burning smell was present.The smoke detector did not go off.There were no sparks or flames.During the machine inspection, the biomed found capacitor 10 on the power control board to be completely charred (or burnt).To resolve the issue, the biomed replaced the entire power supply unit.The biomed said there were 330 hours on the machine.The power supply (and the power control board inside of it) were confirmed to be original fresenius parts.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 machine was returned to service upon completion of the repair.It was confirmed that there was no patient involvement associated with the event.The biomed said the old power supply unit would be sent back for evaluation.
Event or Problem Description
A user facility biomedical technician (biomed) reported that a 2008t hemodialysis (hd) machine powered down during chemical uptake and a small curl of smoke was emitted from the power supply.Additional details were provided upon follow-up with the biomed.The biomed reported that a burning smell was present.The smoke detector did not go off.There were no sparks or flames.During the machine inspection, the biomed found capacitor 10 on the power control board to be completely charred (or burnt).To resolve the issue, the biomed replaced the entire power supply unit.The biomed said there were 330 hours on the machine.The power supply (and the power control board inside of it) were confirmed to be original fresenius parts.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 machine was returned to service upon completion of the repair.It was confirmed that there was no patient involvement associated with the event.The biomed said the old power supply unit would be sent back for evaluation.
Additional Manufacturer Narrative
Additional information: d9, h3 plant investigation: the power supply assembly was returned to the manufacturer for physical evaluation.A visual inspection of the returned part found thermal decomposition on capacitor 10 (c10).There was no other damage found on the power control board or power supply.C10 was replaced for further testing.The power supply was installed onto a test machine for testing.There were no problems during the initial power up.The rinse and heat disinfect programs were completed without any problems or failures.Dialysis mode functioned properly without failures, and a self-test program was completed without failures.The internal visual inspection found no discrepancies.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.Based on evaluation of the returned sample, the reported event was able to be confirmed.

• Brand Name: 2008T HD SYS. CDX W/BIBAG BLUE STAR
• 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: 24185508
• Report Number: 0008030665-2026-00178
• Device Sequence Number: 9649923
• Product Code: KDI
• UDI-Device Identifier: 00840861102099
• UDI-Public: 00840861102099
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K173972
• 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): 05/20/2026

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: 191126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2025
• 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