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	09/12/2025
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
A user facility's biomedical technician (bmt) reported that a 2008t hemodialysis (hd) machine emitted a burning smell from the power supply.A fresenius field service technician (fst) was called onsite and found that the 20-pin cable that connects to the power logic board was burned.Upon follow up, the bmt said that the 20-pin cable was blackened and charred.There was no melting, smoke, sparks flames or arcing.A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction.The machine has 8,000 hours and the 20-pin cable was the original fresenius part on the machine.The bmt reported that there was no damage observed on any other components, or any other additional issues, associated with the burned and charred 20-pin cable.The fst replaced the cable to resolve the issue.Machine functional tests were completed and passed onsite after repair.The bmt confirmed that the unit was returned to service at the user facility without issue and without recurrence of the event.The sample is not available to be returned to the manufacturer for physical evaluation.
Event or Problem Description
A user facility's biomedical technician (bmt) reported that a 2008t hemodialysis (hd) machine emitted a burning smell from the power supply.A fresenius field service technician (fst) was called onsite and found that the 20-pin cable that connects to the power logic board was burned.Upon follow up, the bmt said that the 20-pin cable was blackened and charred.There was no melting, smoke, sparks flames or arcing.A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction.The machine has 8,000 hours and the 20-pin cable was the original fresenius part on the machine.The bmt reported that there was no damage observed on any other components, or any other additional issues, associated with the burned and charred 20-pin cable.The fst replaced the cable to resolve the issue.Machine functional tests were completed and passed onsite after repair.The bmt confirmed that the unit was returned to service at the user facility without issue and without recurrence of the event.The sample is not available to be returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Correction: d9 plant investigation: no parts were returned to the manufacturer for physical evaluation.However, an on-site evaluation was performed by a fresenius field service technician (fst).To resolve the reported issue, the fst replaced the 20-pin cable that connects to the power logic board.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 confirm the reported failure mode.During the machine inspection, the fresenius fst that the 20-pin cable that connects to the power logic board was burned therefore, the complaint event was 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 ; 6174175172
• MDR Report Key: 23097713
• Report Number: 0008030665-2025-02240
• Device Sequence Number: 12953240
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/10/2026

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
• Device Lot Number: N/A
• 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: 09/13/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2020
• 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