MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. 2008T GEN 2 BIBAG WITHOUT CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	190895
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
The biomedical technician (biomed) for a user facility reported to fresenius technical services that thermal decomposition was identified within the 2008t machine.The biomed was replacing a failed diasafe filter when a wire on the v28 wiring harness got caught between the acid pump and the hydraulic frame and burned.The biomed did not observe any burning smell, smoke, spark, flame, arcing, or any other visible heat or electrical damage related to the burned wire.The biomed could not confirm the operating hours of the machine but stated that the part is the original fresenius part on the machine.The biomed stated that the wiring harness was replaced, which resolved the machine issue, and that the machine is back in service without any issues.Additionally, the biomed confirmed that there was no damage observed on any other components, or any other additional issues, associated with the burned wire.The biomed confirmed that a patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction.The biomed confirmed that the sample was discarded and is not available for return to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation and an on-site evaluation was not performed by a fresenius field service technician (fst).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 complaint investigation found objective evidence indicating a product problem, thus the complaint is confirmed.
Event or Problem Description
The biomedical technician (biomed) for a user facility reported to fresenius technical services that thermal decomposition was identified within the 2008t machine.The biomed was replacing a failed diasafe filter when a wire on the v28 wiring harness got caught between the acid pump and the hydraulic frame and burned.The biomed did not observe any burning smell, smoke, spark, flame, arcing, or any other visible heat or electrical damage related to the burned wire.The biomed could not confirm the operating hours of the machine but stated that the part is the original fresenius part on the machine.The biomed stated that the wiring harness was replaced, which resolved the machine issue, and that the machine is back in service without any issues.Additionally, the biomed confirmed that there was no damage observed on any other components, or any other additional issues, associated with the burned wire.The biomed confirmed that a patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction.The biomed confirmed that the sample was discarded and is not available for return to the manufacturer for physical evaluation.

• Brand Name: 2008T GEN 2 BIBAG WITHOUT CDX
• 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: 22895920
• Report Number: 0008030665-2025-02022
• Device Sequence Number: 15692720
• Product Code: KDI
• UDI-Device Identifier: 00840861100927
• UDI-Public: 00840861100927
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K150708
• 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): 10/22/2025

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: Health Professional
• Device Catalogue Number: 190895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2018
• 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