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	08/05/2025
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) reported to fresenius technical support (ts) that a 2008t hemodialysis machine had a burnt wire on the heater rod (blue wire), and the terminal block was burnt.The biomed stated there were thunderstorms in the area which may have contributed to or caused the issue.Ts advised the biomed to replace the heater rod and distribution board.No further details were provided in the initial reporting.Multiple attempts were made to obtain additional information, and thus far no further details have been provided.
Additional Manufacturer Narrative
Additional information: b5, d9, h3 the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
Additional details were provided upon follow-up.The machine was not in use when the thermal damage was identified; the machine was off.The reported issue was discovered during the annual preventive maintenance (pm) check.There were no alarms.No burning smell or arcing was noted, and there were no signs of any smoke, sparks, or flames.The blue wire outside of the plastic melted, and the metal tip was burnt.Photos of the damaged components were provided.The damaged parts were the original fresenius parts on the machine.The machine had 7,250 operating hours on it.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.The biomed fixed the machine by replacing the heater rod and distribution board.The machine has been returned to service.The damaged parts were confirmed to be available to be returned for 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.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).However, the reported complaint was able to be confirmed based on the provided photos.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
Additional details were provided upon follow-up.The machine was not in use when the thermal damage was identified; the machine was off.The reported issue was discovered during the annual preventive maintenance (pm) check.There were no alarms.No burning smell or arcing was noted, and there were no signs of any smoke, sparks, or flames.The blue wire outside of the plastic melted, and the metal tip was burnt.Photos of the damaged components were provided.The damaged parts were the original fresenius parts on the machine.The machine had 7,250 operating hours on it.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.The biomed fixed the machine by replacing the heater rod and distribution board.The machine has been returned to service.The damaged parts were confirmed to be available to be returned for evaluation.

• 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 ; 6174175172
• MDR Report Key: 22891615
• Report Number: 0008030665-2025-02015
• Device Sequence Number: 18381909
• Product Code: KDI
• UDI-Device Identifier: 00840861102082
• UDI-Public: 00840861102082
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2025

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 08/27/2025; 12/03/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 08/27/2025; 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2021
• 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