MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. 2008T GEN 2 BIBAG WITHOUT CDX; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Catalog Number	190895
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Melted (1385); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to fresenius that smoke was coming from the back of the power supply on this 2008t hemodialysis (hd) machine and that a burning smell was noted.A fresenius field service technician (fst) was dispatched to the facility to evaluate the 2008t machine.Additional details were provided upon follow-up with the fst.The fst said the staff called a "code red" from the smoke, but they didn't mention anything about a fire or smoke alarm.The machine was in idle mode when this occurred, and there was no patient involved.The fst said the facility only has hospital grade ground fault circuit interrupter (gfci) outlets on the treatment floor as far as they know.The fst inspected the card cage and power supply, and they observed no issues with the parts.The machine was then connected to a water source, and once connected a steady stream of water began leaking from valve 103 of the bibag hydraulic module.The valve seemed to be the original fresenius part on the machine.The valve had melted, causing the plastic housing to melt and smoke.The rest of the module was inspected with no visual issues noted.No other noticeable damage was noted during the machine inspection.The fst replaced valve 103 and this reportedly resolved the issue.After replacing the valve, the machine underwent alarm and pressure testing.The fst left the back panels off for a bit while running the machine to ensure there were no more leaks or visible smoke.Upon completion of testing, the machine was returned to the staff for use.It was reported that the sample would be returned for manufacturer evaluation.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
It was reported to fresenius that smoke was coming from the back of the power supply on this 2008t hemodialysis (hd) machine and that a burning smell was noted.A fresenius field service technician (fst) was dispatched to the facility to evaluate the 2008t machine.Additional details were provided upon follow-up with the fst.The fst said the staff called a "code red" from the smoke, but they didn't mention anything about a fire or smoke alarm.The machine was in idle mode when this occurred, and there was no patient involved.The fst said the facility only has hospital grade ground fault circuit interrupter (gfci) outlets on the treatment floor as far as they know.The fst inspected the card cage and power supply, and they observed no issues with the parts.The machine was then connected to a water source, and once connected a steady stream of water began leaking from valve 103 of the bibag hydraulic module.The valve seemed to be the original fresenius part on the machine.The valve had melted, causing the plastic housing to melt and smoke.The rest of the module was inspected with no visual issues noted.No other noticeable damage was noted during the machine inspection.The fst replaced valve 103 and this reportedly resolved the issue.After replacing the valve, the machine underwent alarm and pressure testing.The fst left the back panels off for a bit while running the machine to ensure there were no more leaks or visible smoke.Upon completion of testing, the machine was returned to the staff for use.It was reported that the sample would be returned for manufacturer evaluation.
Additional Manufacturer Narrative
Additional information: h3 plant investigation: although a sample was reported to be available for manufacturer evaluation, to date no parts have been received.However, an on-site evaluation was performed by a fresenius field service technician (fst).Additionally, two photos of valve 103 were provided for review.The reported event was confirmed referencing the provided photos.In the photos, the valve appeared melted and swollen exhibiting signs of thermal damage.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.Based on the available information, the complaint event has been confirmed.

• Brand Name: 2008T GEN 2 BIBAG WITHOUT CDX
• 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: 24635021
• Report Number: 0008030665-2026-00530
• Device Sequence Number: 8986029
• Product Code: KDI
• UDI-Device Identifier: 00840861100927
• UDI-Public: 00840861100927
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/30/2026

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: 190895
• Was Device Available for Evaluation?: Yes
• 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: 02/25/2026
• Supplement Date Received by Manufacturer: 07/29/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2015
• 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