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	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical technician for a user facility reported to fresenius technical services that the dry acid mixer was skipping to homogenize mode without filing.The biomed manually filled the mixer with reverse osmosis (ro) water through the top port to prevent delays in treatment.The biomed also stated that another biomed was troubleshooting the issue and attempted to wipe the final fill sensor and received an electrical shock.The biomed did not require medical intervention as a result of this issue.The issue has not reoccurred.No visual indications of thermal decomposition were noted within the system.The biomed stated that the mixer was later tested with water and fill was not skipped.The biomed believes turning the mixer off and on may have reset it and resolved the reported issue.The biomed believes the mixer to be working as intended.No part replacements were required in order to return the mixer to full service.No parts will be returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
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).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 not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
Event or Problem Description
The biomedical technician for a user facility reported to fresenius technical services that the dry acid mixer was skipping to homogenize mode without filing.The biomed manually filled the mixer with reverse osmosis (ro) water through the top port to prevent delays in treatment.The biomed also stated that another biomed was troubleshooting the issue and attempted to wipe the final fill sensor and received an electrical shock.The biomed did not require medical intervention as a result of this issue.The issue has not reoccurred.No visual indications of thermal decomposition were noted within the system.The biomed stated that the mixer was later tested with water and fill was not skipped.The biomed believes turning the mixer off and on may have reset it and resolved the reported issue.The biomed believes the mixer to be working as intended.No part replacements were required in order to return the mixer to full service.No parts will be returned to the manufacturer for physical evaluation.

• 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: 23030522
• Report Number: 0008030665-2025-02179
• Device Sequence Number: 21258118
• Product Code: KPO
• UDI-Device Identifier: 00840861101009
• UDI-Public: 00840861101009
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 05/21/2026

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: 09/04/2025
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2016
• 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