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	03/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility's biomedical technician (bmt) reported that a dry acid mixer would not rinse during rise mode, would not fill and smoke was coming out from under the front panel.A patient was not involved and there was no harm to any individuals because of this malfunction.The front panel was the original fresenius part on the machine.The bmt reported that there was no melting, burning smell, spark, flame, or arcing observed.The bmt reported that there was no damage observed on any other components.The mixer is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The bmt reported that the mixer has not yet been returned to service as he is waiting for parts to arrive.No sample is available to 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.
Event or Problem Description
A user facility's biomedical technician (bmt) reported that a dry acid mixer would not rinse during rise mode, would not fill and smoke was coming out from under the front panel.A patient was not involved and there was no harm to any individuals because of this malfunction.The front panel was the original fresenius part on the machine.The bmt reported that there was no melting, burning smell, spark, flame, or arcing observed.The bmt reported that there was no damage observed on any other components.The mixer is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The bmt reported that the mixer has not yet been returned to service as he is waiting for parts to arrive.No sample is available to be returned to the manufacturer for physical evaluation.
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.
Additional Manufacturer Narrative
Additional information: d9, h3 plant investigation: the actual device was returned to the manufacturer for physical evaluation.The display board control board was received with no visible damage.The display board control board was installed on the board test fixture and showed no issues during test.The device performed as designed.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 was not confirmed.
Event or Problem Description
A user facility's biomedical technician (bmt) reported that a dry acid mixer would not rinse during rise mode, would not fill and smoke was coming out from under the front panel.A patient was not involved and there was no harm to any individuals because of this malfunction.The front panel was the original fresenius part on the machine.The bmt reported that there was no melting, burning smell, spark, flame, or arcing observed.The bmt reported that there was no damage observed on any other components.The mixer is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The bmt reported that the mixer has not yet been returned to service as he is waiting for parts to arrive.No sample is available to be returned to the manufacturer for physical evaluation.

• 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: 21632041
• Report Number: 0008030665-2025-00615
• Device Sequence Number: 9328825
• Product Code: KPO
• UDI-Device Identifier: 00840861100996
• UDI-Public: 00840861100996
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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,Followup
• Report Date (Section B): 05/20/2026

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2025
• Supplement Date Received by Manufacturer: 10/22/2025; 05/20/2026
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 10/29/2025; 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2015
• 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