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	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2024
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 user facility biomedical technician (biomed) reported to fresenius that smoke was smelled and visually observed coming from a dry acid mixer.The reported issue was confirmed during follow-up with the biomed and additional information was obtained.The biomed was contacted by the facility when the dry acid mixer would not start.Plugging the dry acid mixer into a different outlet did not resolve the reported issue.The biomed came onsite to evaluate the mixer.The biomed stated the fill valve would not open.Smoke was smelled and visually observed.The mixer was unplugged and the back door was opened to stop the smoke and clear it.The facility smoke detectors were not triggered.Use of a fire extinguisher was not required.There was no harm to any patients or individuals as a result of the reported issue.Upon removing the fill valve from the machine there were no visual indications of thermal damage noted but it was warm to the touch.The fill valve and control panel were replaced to resolve the reported issue.The mixer was returned to service.The parts were discarded and are not 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 complaint investigation found objective evidence indicating a product problem, thus the complaint is confirmed.
Event or Problem Description
A user facility biomedical technician (biomed) reported to fresenius that smoke was smelled and visually observed coming from a dry acid mixer.The reported issue was confirmed during follow-up with the biomed and additional information was obtained.The biomed was contacted by the facility when the dry acid mixer would not start.Plugging the dry acid mixer into a different outlet did not resolve the reported issue.The biomed came onsite to evaluate the mixer.The biomed stated the fill valve would not open.Smoke was smelled and visually observed.The mixer was unplugged and the back door was opened to stop the smoke and clear it.The facility smoke detectors were not triggered.Use of a fire extinguisher was not required.There was no harm to any patients or individuals as a result of the reported issue.Upon removing the fill valve from the machine there were no visual indications of thermal damage noted but it was warm to the touch.The fill valve and control panel were replaced to resolve the reported issue.The mixer was returned to service.The parts were discarded and are not 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: 18778630
• Report Number: 0002937457-2024-00324
• Device Sequence Number: 12804298
• Product Code: KPO
• UDI-Device Identifier: 00840861100996
• UDI-Public: 00840861100996
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 03/21/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2024
• Supplement Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2023
• 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