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	160147
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
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 biomedical technician (bmt) reported to technical support that a dry acid 132 gallon unit, assy to ship had a leaking fill valve that was received recently.The bmt took the o-ring out of the old fill valve and put it in the new fill valve and it is not leaking.The o-ring he took out was scored.The bmt reported that he did not want the part replaced.Upon follow up, the bmt stated that he replaced the inlet solenoid to resolve the reported issue.The bmt noted that the o-ring inside the solenoid had burned out.The machine is back in service.No parts were returned for evaluation, and no photos are available.The part and lot numbers of the replaced component could not be provided at the time of the call.It was confirmed that there was no patient involvement, harm, or adverse events associated with the reported issue.
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.However, an on-site evaluation was performed by a biomedical technician (bmt).To resolve the reported issue, the bmt replaced the inlet solenoid.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 confirm the reported failure mode.During the machine inspection, the bmt identified that the o-ring inside the solenoid had burned out.Therefore, the complaint event was confirmed.
Event or Problem Description
A biomedical technician (bmt) reported to technical support that a dry acid 132 gallon unit, assy to ship had a leaking fill valve that was received recently.The bmt took the o-ring out of the old fill valve and put it in the new fill valve and it is not leaking.The o-ring he took out was scored.The bmt reported that he did not want the part replaced.Upon follow up, the bmt stated that he replaced the inlet solenoid to resolve the reported issue.The bmt noted that the o-ring inside the solenoid had burned out.The machine is back in service.No parts were returned for evaluation, and no photos are available.The part and lot numbers of the replaced component could not be provided at the time of the call.It was confirmed that there was no patient involvement, harm, or adverse events associated with the reported issue.

• 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: 22571815
• Report Number: 0008030665-2025-01653
• Device Sequence Number: 9700502
• Product Code: KPO
• UDI-Device Identifier: 00840861100996
• UDI-Public: 00840861100996
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2026

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: Health Professional
• Device Catalogue Number: 160147
• 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: 07/15/2025
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2020
• 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