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	08/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.An on-site evaluation was performed by a fresenius field service technician (fst).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.
Event or Problem Description
A fresenius field service technician (fst) was called on-site to service a 2008t hemodialysis (hd) machine that would not power up.The fst found a burnt spot on the motherboard, which caused chain reaction of multiple boards to be damaged.The fst replaced the power control board, main power cable, motherboard, and ui board for power issue.The fst replaced the actuator board for new found issue, act fail error with troubleshooting power issue.The fst replaced the sensor bd fo cond offset reference failure and would not let the fst calibrate the conductivity cells until the sensor board was replaced.The fst replaced the concentrate connector and threaded end because they were fused together.The fst also used a one-year pm kit to replace o-rings, circlip and spacer to complete concentrate connector.There was no patient involvement or patient injury noted.Additional information was requested but was not received to date.
Event or Problem Description
A fresenius field service technician (fst) was called on-site to service a 2008t hemodialysis (hd) machine that would not power up.The fst found a burnt spot on the motherboard, which caused chain reaction of multiple boards to be damaged.The fst replaced the power control board, main power cable, motherboard, and ui board for power issue.The fst replaced the actuator board for new found issue, act fail error with troubleshooting power issue.The fst replaced the sensor bd fo cond offset reference failure and would not let the fst calibrate the conductivity cells until the sensor board was replaced.The fst replaced the concentrate connector and threaded end because they were fused together.The fst also used a one-year pm kit to replace o-rings, circlip and spacer to complete concentrate connector.There was no patient involvement or patient injury noted.Additional information was requested but was not received to date.
Additional Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

• 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: 50611914
• Report Number: 0008030665-2026-02390
• Device Sequence Number: 10742515
• Product Code: KDI
• UDI-Device Identifier: 00840861102112
• UDI-Public: 00840861102112
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/18/2026

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
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2025
• 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