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	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2021
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) contacted fresenius technical support (ts) for assistance with a dry acid 99 gallon mixer that was experiencing issues.The biomed reported that the motor was not turning on during rinse mode.After some troubleshooting, it was believed that the mixer would not fill with water.The biomed replaced the central processing unit (cpu), control board, and power supply, but this did not resolve the issue.The biomed ordered a new fill valve and anticipates that replacing this part will resolve the issue.At the time of follow-up, the biomed was still waiting on the fill valve to arrive.When the biomed replaced the power supply, they noticed that it seemed to be overheating once they started running the mixer to get the motor to turn on.The biomed got a closer look at the power supply and noticed that one of the fuses looked to have been charred.The charring was believed to be caused by heat damage.The biomed confirmed there was no patient involvement associated with the reported event.Multiple attempts have been made obtain additional event details, and thus far, no further information has been provided.The sample is not expected to be returned for 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 investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
Event or Problem Description
A user facility biomedical technician (biomed) contacted fresenius technical support (ts) for assistance with a dry acid 99 gallon mixer that was experiencing issues.The biomed reported that the motor was not turning on during rinse mode.After some troubleshooting, it was believed that the mixer would not fill with water.The biomed replaced the central processing unit (cpu), control board, and power supply, but this did not resolve the issue.The biomed ordered a new fill valve and anticipates that replacing this part will resolve the issue.At the time of follow-up, the biomed was still waiting on the fill valve to arrive.When the biomed replaced the power supply, they noticed that it seemed to be overheating once they started running the mixer to get the motor to turn on.The biomed got a closer look at the power supply and noticed that one of the fuses looked to have been charred.The charring was believed to be caused by heat damage.The biomed confirmed there was no patient involvement associated with the reported event.Multiple attempts have been made obtain additional event details, and thus far, no further information has been provided.The sample is not expected to be returned for evaluation.

• 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
• MDR Report Key: 12393005
• Report Number: 2937457-2021-01822
• Device Sequence Number: 14614660
• Product Code: KPO
• UDI-Device Identifier: 00840861101009
• UDI-Public: 00840861101009
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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
• Report Date (Section B): 10/05/2021

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: 160148
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1