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	11/04/2021
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 fresenius field service technician (fst) reported that a fresenius dry acid mixer at a user facility had a burned display board and a burned pump.The fst was called onsite by the user facility biomedical technician (biomed) after the dry acid mixer would not transfer.The fst found that the pump was wired by the customer incorrectly which burned the pump.The display board, pump, and cpu chip were replaced to resolve the reported issue.There was no harm to any patients or individuals because of this malfunction.Additional information was requested, however a response was not received.The complaint samples were not returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Additional information: plant investigation: the display board assembly, keypad switch panel, and programmed granuflo ii cpu were returned to the manufacturer for a physical evaluation.Inspection of the received display board assembly and keypad switch panel found no discrepancies.The combination of the display board assembly and keypad switch panel were connected to a display board test fixture and passed all testing.Inspection of the received cpu found no discrepancies.The received control board functioned properly on the display board test fixture with the received cpu installed on the board.The motor assembly (pump) was not returned for investigation.During on-site investigation, the field service technician (fst) found that the motor assembly (pump) would not run.The failure was due to the customer wiring the motor assembly incorrectly, which led to the pump motor burning.Therefore, the reported issue has been confirmed.
Event or Problem Description
A fresenius field service technician (fst) reported that a fresenius dry acid mixer at a user facility had a burned display board and a burned pump.The fst was called onsite by the user facility biomedical technician (biomed) after the dry acid mixer would not transfer.The fst found that the pump was wired by the customer incorrectly which burned the pump.The display board, pump, and cpu chip were replaced to resolve the reported issue.There was no harm to any patients or individuals because of this malfunction.Additional information was requested, however a response was not received.The complaint samples were not returned to the manufacturer for physical evaluation.
Event or Problem Description
A fresenius field service technician (fst) reported that a fresenius dry acid mixer at a user facility had a burned display board and a burned pump.The fst was called onsite by the user facility biomedical technician (biomed) after the dry acid mixer would not transfer.The fst found that the pump was wired by the customer incorrectly which burned the pump.The display board, pump, and cpu chip were replaced to resolve the reported issue.There was no harm to any patients or individuals because of this malfunction.Additional information was requested, however a response was not received.The complaint samples were not returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Additional information: g1 plant investigation: no parts were returned to the manufacturer for physical evaluation.However, an on-site evaluation was performed by a fresenius field service technician (fst).To resolve the reported issue, the fst replaced the display board, pump, and cpu chip.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 able to confirm the reported failure mode.During the machine inspection, the fresenius fst evidence of thermal damage.Therefore, the complaint event was confirmed.

• 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: 12869883
• Report Number: 2937457-2021-02340
• Device Sequence Number: 5941883
• Product Code: KPO
• UDI-Device Identifier: 00840861101009
• UDI-Public: 00840861101009
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 06/02/2022

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: 11/04/2021
• Supplement Date Received by Manufacturer: 12/02/2021; 05/18/2022
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 12/15/2021; 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2020
• 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