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

Catalog Number	190766
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2026
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 to fresenius technical support that a 24 volt low alarm occurred during heat disinfect on this 2008t hemodialysis (hd) machine.The biomed reported that the power switch wires looked burnt/corroded.They replaced the 24 volt cable and the power logic cable.Additional details were provided upon follow-up with the biomed.The biomed confirmed the machine was getting a 24 volt low alarm during heat disinfect.There was no patient involvement associated with the event.The biomed said the machine has over 30,000 hours on it - they could not provide an exact number.While troubleshooting the issue, the biomed encountered calibration issues.During the machine evaluation, the biomed discovered thermal damage and corrosion on the wiring harness/terminal that connects to valve 108.There was no damage on valve 108.The biomed also noted a burning smell.There were no signs of any smoke, sparks, or flames.The biomed said there was no other thermal damage noted on the machine.The biomed replaced the damaged wiring harness/terminal.They also replaced the 24 volt cable, the power logic cable, and the entire power supply.After the biomed replaced the power supply, the 24 volt low alarm and calibration issues went away.The biomed was unsure if the machine had ever failed the electrical leakage test.The biomed confirmed the machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The biomed did not have any photos of the damaged wiring harness/terminal.The power supply and damaged components were not available to be sent back for evaluation as they were reportedly discarded.The biomed said the machine was back in service and fully operational.No additional information was available.

• Brand Name: 2008T HEMODIALYSIS SYSTEM W/BIBAG
• 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: 25234379
• Report Number: 0008030665-2026-00966
• Device Sequence Number: 10238105
• Product Code: KDI
• UDI-Device Identifier: 00840861100910
• UDI-Public: 00840861100910
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K231125
• 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): 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: 190766
• 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: 04/28/2026
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2015
• 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