MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. DRY ACID 132 GALLON UNIT, ASSY TO SHIP; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Catalog Number	RTL160147
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
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 services that smoke was coming from the dry acid mixer and it would no longer fill during dissolution and rinse modes.A burn mark was noted on the cabinet of the unit by the drain valve.The biomed was advised to swap the control board and software along with the drain valve if burn/scorch marks were noted on it.Additional information was obtained during follow-up with another facility biomed.There was no harm to any patients or individuals as a result of this malfunction.The mixer was unplugged to extinguish the smoke.It was confirmed that the smoke did not trigger any smoke detectors within the facility.Use of a fire extinguisher was not required.A burning smell was noted upon removing the cover.It was discovered that the black box (the drain valve) that controls the fill function (next to the blue box) and a connected wire were burned.The parts were replaced to resolve the reported issue.No other parts sustained thermal damage and no other issues were identified within the system.The dry acid mixer was returned to service following repair.No photographs are available for review.No parts are available to be returned to the manufacturer for physical evaluation.
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).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.Complaint investigation found objective evidence indicating a product problem, thus the complaint is confirmed.
Event or Problem Description
A user facility biomedical technician (biomed) reported to fresenius technical services that smoke was coming from the dry acid mixer and it would no longer fill during dissolution and rinse modes.A burn mark was noted on the cabinet of the unit by the drain valve.The biomed was advised to swap the control board and software along with the drain valve if burn/scorch marks were noted on it.Additional information was obtained during follow-up with another facility biomed.There was no harm to any patients or individuals as a result of this malfunction.The mixer was unplugged to extinguish the smoke.It was confirmed that the smoke did not trigger any smoke detectors within the facility.Use of a fire extinguisher was not required.A burning smell was noted upon removing the cover.It was discovered that the black box (the drain valve) that controls the fill function (next to the blue box) and a connected wire were burned.The parts were replaced to resolve the reported issue.No other parts sustained thermal damage and no other issues were identified within the system.The dry acid mixer was returned to service following repair.No photographs are available for review.No parts are available to be returned to the manufacturer for physical evaluation.

• Brand Name: DRY ACID 132 GALLON UNIT, ASSY TO SHIP
• Common Device Name: DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
• 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: 21621852
• Report Number: 0008030665-2025-00609
• Device Sequence Number: 6668555
• Product Code: KPO
• UDI-Device Identifier: 00840861100996
• UDI-Public: 00840861100996
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K131611
• 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): 06/29/2026

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: RTL160147
• 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: 03/11/2025
• Supplement Date Received by Manufacturer: 06/24/2026
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2023
• 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