MAUDE Adverse Event Report: CONCORD MANUFACTURING 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	08/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility¿s biomedical technician (bmt) reported that a fresenius dry acid mixer had a cracked, burnt and melted fill valve that emitted a burning smell.There was no report of smoke, sparks, flames or arcing.The issue was noticed during mixing.A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction.The fill valve was the original fresenius part on the machine.The biomed reported that there was no damage observed on any other components, or any other additional issues associated with the reported issue.The biomed is still waiting for a replacement part to arrive, so the mixer is out of service.The fill valve 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. .
Additional Manufacturer Narrative
Plant investigation: the fill valve was returned to the manufacturer for physical evaluation.Exterior inspection revealed thermal damage to the valve coil, the terminals and cracks in the casing.The damaged valve emitted a burn smell.The resistance measured across the hot and neutral terminals was found to be shorted.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 complaint was able to confirm the reported event.
Event or Problem Description
A user facility¿s biomedical technician (bmt) reported that a fresenius dry acid mixer had a cracked, burnt and melted fill valve that emitted a burning smell.There was no report of smoke, sparks, flames or arcing.The issue was noticed during mixing.A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction.The fill valve was the original fresenius part on the machine.The biomed reported that there was no damage observed on any other components, or any other additional issues associated with the reported issue.The biomed is still waiting for a replacement part to arrive, so the mixer is out of service.The fill valve 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): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 20049547
• Report Number: 0002937457-2024-01227
• Device Sequence Number: 7977723
• 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): 10/29/2025

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: 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: 08/19/2024
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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