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	04/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
An area technical operations manager (atom) contacted fresenius technical support (ts) to report a dry acid mixer (132-gallon unit) that had a defective fill valve and control board.Upon inspection of the unit, the atom reported that the fill valve appeared burnt.Additional details were provided upon follow-up with the atom and the biomedical technician (biomed) from the facility where the event occurred.During the fill cycle, it was reported that a burning smell was coming from the mixer, and the mixer wasn¿t filling.It was also reported that smoke was coming from the unit.The biomed had to open the doors to air out the smell inside the mixer room.The smoke did not trigger the smoke alarm to go off.There were no signs of any sparks, arcing, or flames.The facility received a new fill valve, but they are still waiting on a control panel.The defective fill valve, which was confirmed to have evidence of thermal damage on it, was sent back for evaluation.The atom was told that fresenius now uses a different supplier for the fill valves than they used to.The new fill valves pull too much current and tend to run hot, which can blow out the control panel.This was what happened in this instance.No treatments were impacted or missed because of the event.The clinic was able to continue using the mixer by filling it manually.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
An area technical operations manager (atom) contacted fresenius technical support (ts) to report a dry acid mixer (132-gallon unit) that had a defective fill valve and control board.Upon inspection of the unit, the atom reported that the fill valve appeared burnt.Additional details were provided upon follow-up with the atom and the biomedical technician (biomed) from the facility where the event occurred.During the fill cycle, it was reported that a burning smell was coming from the mixer, and the mixer wasn¿t filling.It was also reported that smoke was coming from the unit.The biomed had to open the doors to air out the smell inside the mixer room.The smoke did not trigger the smoke alarm to go off.There were no signs of any sparks, arcing, or flames.The facility received a new fill valve, but they are still waiting on a control panel.The defective fill valve, which was confirmed to have evidence of thermal damage on it, was sent back for evaluation.The atom was told that fresenius now uses a different supplier for the fill valves than they used to.The new fill valves pull too much current and tend to run hot, which can blow out the control panel.This was what happened in this instance.No treatments were impacted or missed because of the event.The clinic was able to continue using the mixer by filling it manually.
Additional Manufacturer Narrative
Additional information: h3 plant investigation: although a sample was reported to be available for manufacturer evaluation, to date no parts have been received.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).However, the complaint investigation was able to find 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 complaint was 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: 19326229
• Report Number: 0002937457-2024-00780
• Device Sequence Number: 20486674
• Product Code: KPO
• UDI-Device Identifier: 00840861100996
• UDI-Public: 00840861100996
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/07/2024

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2022
• 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