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	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2021
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) reported a seized mixing pump.A fresenius fst (field service technician) was called on-site to repair a dry acid mixer that was recirculating which caused the mixing pump to seize due to excessive heat.The pump had severe heat damage and had melted as a result of the seizing.The pump was the original fresenius part on the machine.The fst reported that there was no damage observed on any other components, or any other additional issues, associated with the melted pump.The fst stated that there was no observed burning smell, smoke, spark, flame, arcing, or any other visible heat or electrical damage related to the melting found on the pump.The fst was able to remove the shavings that were holding the pump shaft so they could use the mixer safely.The pump motor was replaced to resolve the reported issue.The mixer is working properly at this time.Functional tests were completed successfully.There was no patient involvement or harm to any individuals because of this malfunction.The fst confirmed that the original pump motor is at the user facility and is available to be returned for physical evaluation.
Additional Manufacturer Narrative
Additional information: d9, h3 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 pump motor.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 identified a melted pump.Therefore, the complaint event was confirmed.
Event or Problem Description
A user facility biomedical technician (biomed) reported a seized mixing pump.A fresenius fst (field service technician) was called on-site to repair a dry acid mixer that was recirculating which caused the mixing pump to seize due to excessive heat.The pump had severe heat damage and had melted as a result of the seizing.The pump was the original fresenius part on the machine.The fst reported that there was no damage observed on any other components, or any other additional issues, associated with the melted pump.The fst stated that there was no observed burning smell, smoke, spark, flame, arcing, or any other visible heat or electrical damage related to the melting found on the pump.The fst was able to remove the shavings that were holding the pump shaft so they could use the mixer safely.The pump motor was replaced to resolve the reported issue.The mixer is working properly at this time.Functional tests were completed successfully.There was no patient involvement or harm to any individuals because of this malfunction.The fst confirmed that the original pump motor is at the user facility and is available to be returned for physical 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
• 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: 12822219
• Report Number: 2937457-2021-02289
• Device Sequence Number: 12166254
• Product Code: KPO
• UDI-Device Identifier: 00840861101009
• UDI-Public: 00840861101009
• Combination Product (Y/N): N
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2021

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: Health Professional
• 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: 11/05/2021
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2020
• 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