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

Model Number	160148
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A biomedical technician (biomed) at a user facility reported that smoke was coming from a fresenius dry acid mixer.The machine was removed from service.The customer requested an onsite evaluation by a fresenius field service technician (fst) however this request was cancelled the following day.There was no reported harm to any patients or individuals because of this malfunction.Additional information was requested, however a response has not been received.No parts were returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
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.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 investigation y the manufacturer did not determines that there was a causal relationship between the objective evidence and the alleged event; the alleged event is unconfirmed.
Event or Problem Description
A biomedical technician (biomed) at a user facility reported that smoke was coming from a fresenius dry acid mixer.The machine was removed from service.The customer requested an onsite evaluation by a fresenius field service technician (fst) however this request was cancelled the following day.There was no reported harm to any patients or individuals because of this malfunction.Additional information was requested, however a response has not been received.No parts were returned to the manufacturer for physical evaluation.
Event or Problem Description
A biomedical technician (biomed) at a user facility reported that smoke was coming from a fresenius dry acid mixer.The machine was removed from service.The customer requested an onsite evaluation by a fresenius field service technician (fst) however this request was cancelled the following day.There was no reported harm to any patients or individuals because of this malfunction.Additional information was requested, however a response has not been received.No parts were returned to the manufacturer for physical evaluation.
Event or Problem Description
A biomedical technician (biomed) at a user facility reported that smoke was coming from a fresenius dry acid mixer.The machine was removed from service.The customer requested an onsite evaluation by a fresenius field service technician (fst) however this request was cancelled the following day.There was no reported harm to any patients or individuals because of this malfunction.Additional information was requested, however a response has not been received.No parts were returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Additional information: d9, h3 plant investigation: the fill valve and display board were returned to the manufacturer for physical evaluation.An external inspection of the fill valve revealed a connector with signs of thermal decomposition.An internal inspection revealed a corroded housing that caused the valve to be stuck.An external inspection of the display board revealed no discrepancies.The display board was connected to a test dry acid dissolution unit, and the display worked as intended.The manufacturer investigation confirmed the reported issue.

• 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: 15200827
• Report Number: 0002937457-2022-01332
• Device Sequence Number: 6242200
• Product Code: KPO
• UDI-Device Identifier: 00840861101009
• UDI-Public: 00840861101009
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/10/2023

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 Model Number: 160148
• Device Catalogue Number: RTL160148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2022
• Supplement Date Received by Manufacturer: 08/11/2022; 02/10/2023; 02/10/2023
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 08/23/2022; 02/10/2023; 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2019
• 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