MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. 2008T HD SYS. W/O CDX W/BIBAG BLUE STAR; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Catalog Number	191130
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A fresenius field service technician (fst) was called on-site to repair a 2008t hemodialysis (hd) machine that had an actuator board that kept blowing integrated circuit 12.The fst replaced the acid pump, bicarbonate pump, ultrafiltration (uf) pump, the actuator board and negative temperature coefficient (ntc) #3 to resolve the issue.Machine functional tests were completed and passed onsite after repair.Upon follow-up, the user facility biomedical technician (bmt) stated the machine was repaired successfully by the fst.A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals due to the reported event.The bmt stated the machine had approximately 15,500 hours at the time of the repair.The bmt indicated no components actually blew up but that the integrated circuit did apear burnt.There was no reported visible damage to any other components.The bmt stated there was no burning smell, smoke, spark, flame, or arcing related to the reported event.The bmt reported the acid pump, bicarb pump, uf pump and the actuator board were replaced by the fst which resolved the issue.Per bmt it was unknown which component was causing the integrated circuit to fail, and the fst ended replacing all the pumps along with the actuator board to resolve the issue.The machine has since been returned to service without reoccurrence of the event.The components were discarded and were no longer available to be returned to the manufacturer for physical evaluation.
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 fresenius field service technician (fst) was called on-site to repair a 2008t hemodialysis (hd) machine that had an actuator board that kept blowing integrated circuit 12.The fst replaced the acid pump, bicarbonate pump, ultrafiltration (uf) pump, the actuator board and negative temperature coefficient (ntc) #3 to resolve the issue.Machine functional tests were completed and passed onsite after repair.Upon follow-up, the user facility biomedical technician (bmt) stated the machine was repaired successfully by the fst.A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals due to the reported event.The bmt stated the machine had approximately 15,500 hours at the time of the repair.The bmt indicated no components actually blew up but that the integrated circuit did apear burnt.There was no reported visible damage to any other components.The bmt stated there was no burning smell, smoke, spark, flame, or arcing related to the reported event.The bmt reported the acid pump, bicarb pump, uf pump and the actuator board were replaced by the fst which resolved the issue.Per bmt it was unknown which component was causing the integrated circuit to fail, and the fst ended replacing all the pumps along with the actuator board to resolve the issue.The machine has since been returned to service without reoccurrence of the event.The components were discarded and were no longer available to be returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.Field service technician 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.

• Brand Name: 2008T HD SYS. W/O CDX W/BIBAG BLUE STAR
• 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: 24918072
• Report Number: 0008030665-2026-00735
• Device Sequence Number: 10330723
• Product Code: KDI
• UDI-Device Identifier: 00840861102112
• UDI-Public: 00840861102112
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K243237
• 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): 07/29/2026

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: 191130
• 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: 04/03/2026
• Supplement Date Received by Manufacturer: 07/29/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2020
• 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