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	12/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A biomedical technician (bmt) reported a dry acid mixer was not filling with no power to the pump.It was noted there were burned fuses (f1/f2) and a fluid leak from the hydraulics.The machine was unable to be repaired and the bmt was advised to purchase a new mixer.There was no patient involvement and no patient injury.Additional information was requested but was not received to date.
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 biomedical technician (bmt) reported a dry acid mixer was not filling with no power to the pump.It was noted there were burned fuses (f1/f2) and a fluid leak from the hydraulics.The machine was unable to be repaired and the bmt was advised to purchase a new mixer.There was no patient involvement and no patient injury.Additional information received via email.The bmt stated the issue was attributed to wear and tear.The pump was not replaced and there was no issue with the pump.The issue was attributed to blown fuses and there were no other noted burned components.The bmt stated there was no issue with the pump and no hydraulic leak.The unit was repaired.The hours on the unit mixer was not able to be provided.Per bmt the power supply board was purchased and installed on the mixer by the bmt team in the area.The machine was placed back in service without issue.No additional information was provided.
Event or Problem Description
A biomedical technician (bmt) reported a dry acid mixer was not filling with no power to the pump.It was noted there were burned fuses (f1/f2) and a fluid leak from the hydraulics.The machine was unable to be repaired and the bmt was advised to purchase a new mixer.There was no patient involvement and no patient injury.Additional information received via email.The bmt stated the issue was attributed to wear and tear.The pump was not replaced and there was no issue with the pump.The issue was attributed to blown fuses and there were no other noted burned components.The bmt stated there was no issue with the pump and no hydraulic leak.The unit was repaired.The hours on the unit mixer was not able to be provided.Per bmt the power supply board was purchased and installed on the mixer by the bmt team in the area.The machine was placed back in service without issue.No additional information was provided.
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.The investigation into the cause of the reported problem was confirmed.A definitive conclusion regarding the complaint incident was determined to be traced to component failure.

• 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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 13029055
• Report Number: 2937457-2021-02465
• Device Sequence Number: 17226355
• Product Code: KPO
• UDI-Device Identifier: 00840861101009
• UDI-Public: 00840861101009
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/05/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2021
• Supplement Date Received by Manufacturer: 12/21/2021; 01/04/2022
• Initial Report FDA Received Date: 12/17/2021
• Supplement Report FDA Received Date: 12/21/2021; 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2017
• 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