MAUDE Adverse Event Report: CONCORD MANUFACTURING 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	03/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A hemodialysis (hd) user facility requested onsite service from fresenius to repair a 132-gallon dry acid mixer that was experiencing filling issues.A fresenius field service technician (fst) was dispatched to the user facility to evaluate the machine.The fst verified the reported failure, indicating that water was not entering the tank during fill mode.The fst found that the inlet water valve was not opening and needed to be replaced.The fst replaced the inlet water valve to resolve the reported issue.As a precaution, the fst also replaced the control console.Upon completion of the repair, the fst verified the mixer was working correctly and was filling during the fill step.A fill valve was returned to the manufacturer for physical evaluation.Upon evaluation of the returned part, thermal damage was identified.
Additional Manufacturer Narrative
Plant investigation: a fill valve was returned to the manufacturer for physical evaluation.An external visual inspection of the part revealed there was thermal damage on the valve coil and cracks in the casing.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.Based on the results of the investigation, the reported event was able to be confirmed.

• 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: 19160760
• Report Number: 0002937457-2024-00668
• Device Sequence Number: 7937853
• 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
• Report Date (Section B): 04/22/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2024
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2022
• 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