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 Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2024
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 finding thermal damage on a dry acid (132 gallon unit) mixer.The biomed initially contacted technical support (ts) due to the mixer not filling.During follow-up it was revealed that a burning smell was also noted.Upon further investigation the biomed noticed the fill valve was burnt, and so was the control board.In the initial reporting it was documented that the fill valve "smoked".However, during follow-up the biomed stated they did not see any smoke, sparks, or flames.They were able to fix the machine by replacing the fill valve and the control board.The reported issue did not impact any patient treatments.The biomed said the machine was repaired the same day the filling issues started, and the repair only took approximately one hour.There were no photos of the thermal damage to provide, and the biomed said the damaged parts were discarded.
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 complaint investigation found objective evidence indicating a product problem, 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.Based on the available information, the reported event has been confirmed.
Event or Problem Description
A user facility biomedical technician (biomed) reported finding thermal damage on a dry acid (132 gallon unit) mixer.The biomed initially contacted technical support (ts) due to the mixer not filling.During follow-up it was revealed that a burning smell was also noted.Upon further investigation the biomed noticed the fill valve was burnt, and so was the control board.In the initial reporting it was documented that the fill valve "smoked".However, during follow-up the biomed stated they did not see any smoke, sparks, or flames.They were able to fix the machine by replacing the fill valve and the control board.The reported issue did not impact any patient treatments.The biomed said the machine was repaired the same day the filling issues started, and the repair only took approximately one hour.There were no photos of the thermal damage to provide, and the biomed said the damaged parts were discarded.

• 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: 21174857
• Report Number: 0008030665-2025-00145
• Device Sequence Number: 4286819
• Product Code: KPO
• UDI-Device Identifier: 00840861100996
• UDI-Public: 00840861100996
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 03/08/2026

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: 12/31/2024
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 03/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2019
• 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