MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Catalog Number	190610
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
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 fresenius field service technician (fst) reported that during annual preventative maintenance a 2008k2 hemodialysis (hd) machine's ntc2 and ntc3 wire sheath was melted.The fst replaced the ntc2 and ntc3 to resolve the issue.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 11,852 hours and the ntc2 and ntc3 were the original fresenius parts on the machine.During follow up, the biomedical technician (bmt) reported that there was no charring, blackening, burning smell, smoke, spark, flame, or arcing observed.The bmt reported that the machine has not had any past problems with failing the electrical leakage test and that there was no damage observed on any other components.Machine functional tests were completed and passed onsite after repair.The complaint device is not available to be returned to the manufacturer for evaluation.
Event or Problem Description
A fresenius field service technician (fst) reported that during annual preventative maintenance a 2008k2 hemodialysis (hd) machine's ntc2 and ntc3 wire sheath was melted.The fst replaced the ntc2 and ntc3 to resolve the issue.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 11,852 hours and the ntc2 and ntc3 were the original fresenius parts on the machine.During follow up, the biomedical technician (bmt) reported that there was no charring, blackening, burning smell, smoke, spark, flame, or arcing observed.The bmt reported that the machine has not had any past problems with failing the electrical leakage test and that there was no damage observed on any other components.Machine functional tests were completed and passed onsite after repair.The complaint device is not available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
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.

• Brand Name: 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
• 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: 23337216
• Report Number: 0008030665-2025-02500
• Device Sequence Number: 20776102
• Product Code: KDI
• UDI-Device Identifier: 00840861100859
• UDI-Public: 00840861100859
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K153449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2026

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: 190610
• 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: 10/17/2025
• Supplement Date Received by Manufacturer: 07/24/2026
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2009
• 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