MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. 2008T HD SYS. W/O CDX BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	191128
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
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) contacted fresenius technical support because a crit-line device was not passing the verification test on a 2008t hemodialysis machine.There was no patient involvement associated with the event.The biomed was requesting assistance to have the device verified.A fresenius field service technician (fst) was dispatched to the facility to evaluate the machine.The fst confirmed the crit-line device would not pass the verification test.The fst tried the crit-line device on other known good machines, and it would not pass the test on those machines either.During evaluation of the original machine in question, the fst found a burnt diode on the functional board.The fst said this diode controls the front usb port board.No other components were found to be damaged.To resolve the reported issue, the biomed replaced the usb port board and the functional board.There was no burning smell, and there were no signs of any smoke, sparks, or flames.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet and had no previous history of failing the electrical leakage test.At the time of the repair, the machine had 437 operating hours on it.The machine was returned to service upon completion of the repair.The crit-line was bagged by the customer and labeled with the message "do not use".The fst agreed to return the functional board for evaluation.A photo of the damaged functional board was provided for review.
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).The fst found objective evidence indicating 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.The reported event has been confirmed.
Event or Problem Description
A user facility biomedical technician (biomed) contacted fresenius technical support because a crit-line device was not passing the verification test on a 2008t hemodialysis machine.There was no patient involvement associated with the event.The biomed was requesting assistance to have the device verified.A fresenius field service technician (fst) was dispatched to the facility to evaluate the machine.The fst confirmed the crit-line device would not pass the verification test.The fst tried the crit-line device on other known good machines, and it would not pass the test on those machines either.During evaluation of the original machine in question, the fst found a burnt diode on the functional board.The fst said this diode controls the front usb port board.No other components were found to be damaged.To resolve the reported issue, the biomed replaced the usb port board and the functional board.There was no burning smell, and there were no signs of any smoke, sparks, or flames.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet and had no previous history of failing the electrical leakage test.At the time of the repair, the machine had 437 operating hours on it.The machine was returned to service upon completion of the repair.The crit-line was bagged by the customer and labeled with the message "do not use".The fst agreed to return the functional board for evaluation.A photo of the damaged functional board was provided for review.
Additional Manufacturer Narrative
Additional information: d9, h3 plant investigation: the functional board was returned to the manufacturer for physical evaluation.The visual inspection of the returned sample showed there was thermal decomposition on the control coil (l16).Based on the sample evaluation, the reported event has been confirmed.
Event or Problem Description
A user facility biomedical technician (biomed) contacted fresenius technical support because a crit-line device was not passing the verification test on a 2008t hemodialysis machine.There was no patient involvement associated with the event.The biomed was requesting assistance to have the device verified.A fresenius field service technician (fst) was dispatched to the facility to evaluate the machine.The fst confirmed the crit-line device would not pass the verification test.The fst tried the crit-line device on other known good machines, and it would not pass the test on those machines either.During evaluation of the original machine in question, the fst found a burnt diode on the functional board.The fst said this diode controls the front usb port board.No other components were found to be damaged.To resolve the reported issue, the biomed replaced the usb port board and the functional board.There was no burning smell, and there were no signs of any smoke, sparks, or flames.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet and had no previous history of failing the electrical leakage test.At the time of the repair, the machine had 437 operating hours on it.The machine was returned to service upon completion of the repair.The crit-line was bagged by the customer and labeled with the message "do not use".The fst agreed to return the functional board for evaluation.A photo of the damaged functional board was provided for review.

• Brand Name: 2008T HD SYS. W/O 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 ; 6174175172
• MDR Report Key: 22856382
• Report Number: 0008030665-2025-01964
• Device Sequence Number: 18462996
• Product Code: KDI
• UDI-Device Identifier: 00840861102105
• UDI-Public: 00840861102105
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 03/08/2026

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: Health Professional
• Device Catalogue Number: 191128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 10/21/2025; 03/04/2026
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 10/22/2025; 03/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2021
• 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