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 Codes	Thermal Decomposition of Device (1071); Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility biomedical technician (biomed) contacted fresenius medical care (fme) technical support (ts) to report that a 2008k2 hemodialysis machine would not power on.The biomed stated the machine stops during power-up (at 15% of initialization) and just audibly alarms.It does not continue powering up.During troubleshooting the biomed noticed a defective wire (scorched) on the power switch in the power supply.They replaced the power supply assembly with another module (unknown to be good or not).The biomed also replaced the motherboard.The biomed unplugged the actuator/sensor cables from the distribution board and the problem continues to occur.Ts recommended the biomed replace the functional board or power logic board.The biomed was also advised to swap the power supply with a known good module.Upon follow-up with the biomed, it was reported that the power issue was resolved by replacing the functional board.The biomed said the replacement functional board was ordered through a third-party vendor, and the defective functional board was sent back to the vendor as part of an exchange.The biomed confirmed thermal damage was found during troubleshooting.One of the power supply wires was charred and melted.No burning smell was noticed.There were no signs of any smoke, sparks, or flames.A photo of the thermal damage could not be provided.The biomed confirmed the power assembly was the original fme manufactured part on the machine.No other parts or components appeared to be damaged.The biomed said the machine has approximately 23,000 operating hours on it.It was confirmed the machine had no history of failing the electrical leakage test.When in use, the biomed confirmed the machine remains plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The power supply assembly that exhibited thermal damage was not available to be sent back for evaluation as it was reportedly discarded.The biomed confirmed the machine was back in service and fully operational.There was no patient involvement associated with this event.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

• 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: 50287017
• Report Number: 0008030665-2026-02215
• Device Sequence Number: 13446791
• Product Code: KDI
• UDI-Device Identifier: 00840861100859
• UDI-Public: 00840861100859
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 08/17/2026

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
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2026
• Initial Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2015
• 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