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	02/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: 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 (bmt) reported the 2008t hemodialysis (hd) machine dialysis mode was greyed out.The bmt found the mother board and eeprom (electrically erasable programmable read-only memory) had thermal damage.The bmt was advised to replace the motherboard and eeprom.There was no patient involvement or injury noted at intake.Upon follow-up, the bmt stated the machine dialysis mode was greyed out during preventative maintenance (pm) and confirmed there was no patient involvement or injury as a result of the reported event.The bmt stated upon examination it was determined the mother board and eeprom appeared to have thermal damage.The bmt stated the replacement motherboard and eeprom were received today and the machine remains out of service pending replacement of the parts.Other than the thermal damage noted on the motherboard and eeprom, no further thermal damage was found on any other machine components.There was no smoke, burning smell, or any signs of arcing, sparks, or flames.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet, and there was no previous history of the machine failing the electrical leakage test.The bmt was unable to provide the number of operating hours on the machine at the time of the call.The damaged parts were available to be returned for evaluation.There was no patient involvement associated with the reported event.
Additional Manufacturer Narrative
Additional information: d9, h3 plant investigation: the product was not returned; a physical investigation could not be performed.Complaint investigation found objective evidence indicating a product problem, thus the complaint is confirmed.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 be confirmed.
Event or Problem Description
A user facility biomedical technician (bmt) reported the 2008t hemodialysis (hd) machine dialysis mode was greyed out.The bmt found the mother board and eeprom (electrically erasable programmable read-only memory) had thermal damage.The bmt was advised to replace the motherboard and eeprom.There was no patient involvement or injury noted at intake.Upon follow-up, the bmt stated the machine dialysis mode was greyed out during preventative maintenance (pm) and confirmed there was no patient involvement or injury as a result of the reported event.The bmt stated upon examination it was determined the mother board and eeprom appeared to have thermal damage.The bmt stated the replacement motherboard and eeprom were received today and the machine remains out of service pending replacement of the parts.Other than the thermal damage noted on the motherboard and eeprom, no further thermal damage was found on any other machine components.There was no smoke, burning smell, or any signs of arcing, sparks, or flames.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet, and there was no previous history of the machine failing the electrical leakage test.The bmt was unable to provide the number of operating hours on the machine at the time of the call.The damaged parts were available to be returned for evaluation.There was no patient involvement associated with the reported event.

• 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: 24461639
• Report Number: 0008030665-2026-00403
• Device Sequence Number: 9403588
• Product Code: KDI
• UDI-Device Identifier: 00840861100910
• UDI-Public: 00840861100910
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2026

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: 02/19/2026
• Supplement Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2016
• 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