MAUDE Adverse Event Report: CONCORD MANUFACTURING DRY ACID 99 GALLON UNIT, ASSY TO SHIP; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Catalog Number	RTL160148
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility biomedical technician (bmt) reported during dissolution mode and after mixing there were black specks in the granflo concentrate and only two jets were working.The bmt reported smoke was seen in the tank.The bmt was advised to check the pump head to see if it failed and to check under the machine to see if any of the valves had been leaked on and check the electronics for failed components.Upon follow-up, the bmt stated the smoke was observed in the tank and confirmed there was no burnt components, spark or flame noted as a result of the reported event.The bmt stated the power supply and all components were examined and no thermal damage was noted.There was no patient involvement, patient harm, or adverse event reported.The mixer remains out of service pending receipt and replacement of pump assembly and jet valve.It was reported the replaced components were no longer available for investigation.
Additional Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.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.Complaint investigation found objective evidence indicating a product problem, thus the complaint is confirmed.
Event or Problem Description
A user facility biomedical technician (bmt) reported during dissolution mode and after mixing there were black specks in the granflo concentrate and only two jets were working.The bmt reported smoke was seen in the tank.The bmt was advised to check the pump head to see if it failed and to check under the machine to see if any of the valves had been leaked on and check the electronics for failed components.Upon follow-up, the bmt stated the smoke was observed in the tank and confirmed there was no burnt components, spark or flame noted as a result of the reported event.The bmt stated the power supply and all components were examined and no thermal damage was noted.There was no patient involvement, patient harm, or adverse event reported.The mixer remains out of service pending receipt and replacement of pump assembly and jet valve.It was reported the replaced components were no longer available for investigation.

• Brand Name: DRY ACID 99 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: 17558386
• Report Number: 0002937457-2023-01222
• Device Sequence Number: 17372739
• Product Code: KPO
• UDI-Device Identifier: 00840861101009
• UDI-Public: 00840861101009
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2023

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: RTL160148
• 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: 08/14/2023
• Supplement Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2020
• 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