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

Catalog Number	191126
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
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 to fresenius technical support that a 2008t hemodialysis (hd) machine displayed an 'e.08' alarm with an 'art.Bp no comm' message during the select program screen.Additional details were provided upon follow-up with the biomed.There was no patient involvement associated with the event.The biomed first tried replacing the lp955 board, but this did not resolve the issue.During troubleshooting, the biomed found thermal damage on the blood pump motor.No other parts were found to be damaged.The biomed said when they opened up where the motor brushes are, they noticed that it was packed full of black dust.After clearing the debris, the biomed could see that the white plastic around the motor brushes was blackened and melted.No burning smell was noted.The biomed confirmed there were no signs of smoke, sparks, or flames.The biomed replaced the blood pump motor and the alarms went away.The blood pump motor was reported to be the original fresenius part on the machine.The biomed confirmed the machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet and had no past problems with failing the electrical leakage test.The machine had 24,393 operating hours on it.The damaged part was not available to be sent back for evaluation as it was reportedly discarded.However, photos of the blood pump motor were provided for review.
Event or Problem Description
A user facility biomedical technician (biomed) reported to fresenius technical support that a 2008t hemodialysis (hd) machine displayed an 'e.08' alarm with an 'art.Bp no comm' message during the select program screen.Additional details were provided upon follow-up with the biomed.There was no patient involvement associated with the event.The biomed first tried replacing the lp955 board, but this did not resolve the issue.During troubleshooting, the biomed found thermal damage on the blood pump motor.No other parts were found to be damaged.The biomed said when they opened up where the motor brushes are, they noticed that it was packed full of black dust.After clearing the debris, the biomed could see that the white plastic around the motor brushes was blackened and melted.No burning smell was noted.The biomed confirmed there were no signs of smoke, sparks, or flames.The biomed replaced the blood pump motor and the alarms went away.The blood pump motor was reported to be the original fresenius part on the machine.The biomed confirmed the machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet and had no past problems with failing the electrical leakage test.The machine had 24,393 operating hours on it.The damaged part was not available to be sent back for evaluation as it was reportedly discarded.However, photos of the blood pump motor were provided for review.
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 reported event was able to be confirmed referencing the provided photos.The photos show multiple angles of the dc motor where thermal damage was visible.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 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: 24683558
• Report Number: 0008030665-2026-00561
• Device Sequence Number: 9854979
• Product Code: KDI
• UDI-Device Identifier: 00840861102099
• UDI-Public: 00840861102099
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K173972
• 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): 07/29/2026

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: 191126
• 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: 03/04/2026
• Supplement Date Received by Manufacturer: 07/24/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2019
• 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