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	03/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A biomedical technician (biomed) at a user facility reported that a fresenius dry acid mixer was not filling and had a burning smell coming from the fill valve.The fill valve had charring on the body of the valve and a little smoke was observed.The facility¿s smoke detectors did not go off as a result.The charred valve was noticed during machine repair.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 machine hours are unknown.The fill valve was the original fresenius part on the machine.The mixer is plugged in to a hospital grade ground-fault circuit interrupter (gfci) outlet.The bmt reported that there was no damage observed on any other components, or any other additional issues, associated with the charred fill valve.The bmt replaced the control board and the fill valve to resolve the reported issue.The unit was returned to service at the user facility without issue and without reoccurrence of the event.The fill valve was returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An 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 review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.Upon completion of the evaluation, the reported issue was confirmed.
Event or Problem Description
A biomedical technician (biomed) at a user facility reported that a fresenius dry acid mixer was not filling and had a burning smell coming from the fill valve.The fill valve had charring on the body of the valve and a little smoke was observed.The facility¿s smoke detectors did not go off as a result.The charred valve was noticed during machine repair.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 machine hours are unknown.The fill valve was the original fresenius part on the machine.The mixer is plugged in to a hospital grade ground-fault circuit interrupter (gfci) outlet.The bmt reported that there was no damage observed on any other components, or any other additional issues, associated with the charred fill valve.The bmt replaced the control board and the fill valve to resolve the reported issue.The unit was returned to service at the user facility without issue and without reoccurrence of the event.The fill valve was returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Correction: h6 health effect impact code.

• 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: 19184672
• Report Number: 0002937457-2024-00686
• Device Sequence Number: 12549706
• 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,Followup
• Report Date (Section B): 05/03/2024

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: Health Professional
• Device Catalogue Number: RTL160147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2024
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2022
• 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