MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. DRY ACID 99 GALLON UNIT, ASSY TO SHIP; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Catalog Number	RTL160148
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A biomedical technician (bmt) reported there was no water coming through the jet valves or the recirculation valve in dissolution/rinse modes.The pump assembly was working in transfer and drain modes (no issues with the pump/fluid movement).The bmt was advised to check for any corrosion issues with the wiring harnesses going to the jet or recirculation valves under the tank (check for fluid leaks) or swap the control board assembly.There was no patient involvement or injury noted at intake.Upon follow-up, the bmt stated they replaced the solenoid valve to resolve the reported issue.The valve looked burnt but did not smell burnt.There was water on the electronic part of the valve, which was shorted.The mixer was back in service.No photos were available.No parts were returned for evaluation.The bmt was unable to provide the serial number or lot number of the product(s) replaced.It was confirmed there was no patient involvement, harm, or adverse events associated with the reported issue.
Additional Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
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).Complaint investigation found objective evidence indicating a product problem, thus the complaint is 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 investigation into the cause of the reported problem was able to be confirmed.
Event or Problem Description
A biomedical technician (bmt) reported there was no water coming through the jet valves or the recirculation valve in dissolution/rinse modes.The pump assembly was working in transfer and drain modes (no issues with the pump/fluid movement).The bmt was advised to check for any corrosion issues with the wiring harnesses going to the jet or recirculation valves under the tank (check for fluid leaks) or swap the control board assembly.There was no patient involvement or injury noted at intake.Upon follow-up, the bmt stated they replaced the solenoid valve to resolve the reported issue.The valve looked burnt but did not smell burnt.There was water on the electronic part of the valve, which was shorted.The mixer was back in service.No photos were available.No parts were returned for evaluation.The bmt was unable to provide the serial number or lot number of the product(s) replaced.It was confirmed there was no patient involvement, harm, or adverse events associated with the reported issue.

• Brand Name: DRY ACID 99 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: 23889220
• Report Number: 0008030665-2025-03094
• Device Sequence Number: 15865557
• Product Code: KPO
• UDI-Device Identifier: 00840861101009
• UDI-Public: 00840861101009
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 06/24/2026

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: RTL160148
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 06/24/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2019
• 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