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); Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
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
An area technical operations manager (atom) reported finding thermal damage on the fill valve of a dry acid 132 gallon unit mixer at a hemodialysis (hd) clinic.The original issue was that the mixer was experiencing power issues while being used.There was also a mild burning smell noted.After some investigation, the atom identified thermal damage on the fill valve and the connector of the fill valve cable.The components displayed evidence of melting and thermal decomposition.The atom replaced the fill valve and fill valve cable with new parts.Afterwards, the mixer began experiencing another issue where the fill valve would not close causing the mixer to overflow.The atom was unsure if the new fill valve was bad, or if there was an issue with the control board.To further troubleshoot, the atom borrowed the control board from a mixer at a different clinic.With this other control board, the atom said the fill valve was closing.After determining that the control board had to be replaced as well, the atom ordered a new one.The control board was replaced and the machine was confirmed to be fully operational again.The atom confirmed there were no signs of any smoke, sparks, or flames.Additionally, there was no impact to any patient treatments.The facility had mixed enough acid prior to the events to hold them over, and they were able to mix another batch after borrowing the control board from the neighboring clinic.The damaged fill valve and fill valve cable were not available to be sent back for evaluation as they were reportedly discarded, and no photos were provided for review.
Event or Problem Description
An area technical operations manager (atom) reported finding thermal damage on the fill valve of a dry acid 132 gallon unit mixer at a hemodialysis (hd) clinic.The original issue was that the mixer was experiencing power issues while being used.There was also a mild burning smell noted.After some investigation, the atom identified thermal damage on the fill valve and the connector of the fill valve cable.The components displayed evidence of melting and thermal decomposition.The atom replaced the fill valve and fill valve cable with new parts.Afterwards, the mixer began experiencing another issue where the fill valve would not close causing the mixer to overflow.The atom was unsure if the new fill valve was bad, or if there was an issue with the control board.To further troubleshoot, the atom borrowed the control board from a mixer at a different clinic.With this other control board, the atom said the fill valve was closing.After determining that the control board had to be replaced as well, the atom ordered a new one.The control board was replaced and the machine was confirmed to be fully operational again.The atom confirmed there were no signs of any smoke, sparks, or flames.Additionally, there was no impact to any patient treatments.The facility had mixed enough acid prior to the events to hold them over, and they were able to mix another batch after borrowing the control board from the neighboring clinic.The damaged fill valve and fill valve cable were not available to be sent back for evaluation as they were reportedly discarded, and no photos were provided for review.
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).However, the manufacturing plant was able to find objective evidence indicating a product problem had occurred and thus the complaint was 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 reported event has been confirmed.

• 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: 21896365
• Report Number: 0008030665-2025-00938
• Device Sequence Number: 19693510
• Product Code: KPO
• UDI-Device Identifier: 00840861100996
• UDI-Public: 00840861100996
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/20/2025

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: 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: 04/14/2025
• Supplement Date Received by Manufacturer: 10/18/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2018
• 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