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

Catalog Number	191124
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility biomedical technician (biomed) reported that a 2008t machine was powering off when attempting to put it into a rinse cycle or dialysis mode.There was no patient involvement associated with the event.The biomed referenced the troubleshooting manual and it advised to check the actuator board.Upon inspection of the board, the biomed noticed thermal damage (a black spot).The biomed replaced the actuator board with a spare and this resolved the issue.There was no burning smell noted.There were no signs of any smoke, sparks, or flames.The biomed confirmed the machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet and it did not have a history of failing the electrical leakage test.The biomed stated the machine has about 16,000 hours on it.No photos of the damaged board were available.The board was not available to be sent back for evaluation as it was reportedly discarded.The machine was returned to service upon completion of the repair.No additional information was available.
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 that a 2008t machine was powering off when attempting to put it into a rinse cycle or dialysis mode.There was no patient involvement associated with the event.The biomed referenced the troubleshooting manual and it advised to check the actuator board.Upon inspection of the board, the biomed noticed thermal damage (a black spot).The biomed replaced the actuator board with a spare and this resolved the issue.There was no burning smell noted.There were no signs of any smoke, sparks, or flames.The biomed confirmed the machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet and it did not have a history of failing the electrical leakage test.The biomed stated the machine has about 16,000 hours on it.No photos of the damaged board were available.The board was not available to be sent back for evaluation as it was reportedly discarded.The machine was returned to service upon completion of the repair.No additional information was available.
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).However, the complaint investigation found objective evidence indicating there was a product problem, and thus the complaint was 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.Based on the available information, the reported event has been confirmed.

• Brand Name: 2008T HD SYS. CDX 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: 25408891
• Report Number: 0008030665-2026-01127
• Device Sequence Number: 10311658
• Product Code: KDI
• UDI-Device Identifier: 00840861102082
• UDI-Public: 00840861102082
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 07/31/2026

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: 191124
• 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: 05/19/2026
• Supplement Date Received by Manufacturer: 07/20/2026
• Initial Report FDA Received Date: 06/05/2026
• Supplement Report FDA Received Date: 07/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2019
• 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