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	11/02/2021
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 biomedical technician (biomed) at a user facility reported that a fresenius hemodialysis (hd) dry acid mixer had a motor that was not mixing.The field service technician (fst) found a pump head that was burned out.The burned pump head was initially noticed during machine repair for the mixer improperly detecting water inside.The biomed did not observe any burning smell, smoke, spark, flame, arcing, or any other visible heat or electrical damage related to the burning found on the pump head.There was no harm to any patients or individuals because of this malfunction.The biomed reported that the pump is the original fresenius part on the machine and that there was no damage observed on any other components associated with the burned pump head.The biomed replaced the dry level sensor and pump, which resolved the issue.The unit was returned to service at the user facility without issue and without reoccurrence of the event.The pump is available to be returned to the manufacturer for physical evaluation.
Event or Problem Description
A biomedical technician (biomed) at a user facility reported that a fresenius hemodialysis (hd) dry acid mixer had a motor that was not mixing.The field service technician (fst) found a pump head that was burned out.The burned pump head was initially noticed during machine repair for the mixer improperly detecting water inside.The biomed did not observe any burning smell, smoke, spark, flame, arcing, or any other visible heat or electrical damage related to the burning found on the pump head.There was no harm to any patients or individuals because of this malfunction.The biomed reported that the pump is the original fresenius part on the machine and that there was no damage observed on any other components associated with the burned pump head.The biomed replaced the dry level sensor and pump, which resolved the issue.The unit was returned to service at the user facility without issue and without reoccurrence of the event.The pump is available to be returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Additional information: d9, g1, h3 plant investigation: the actual device was returned to the manufacturer for physical evaluation.An exterior visual inspection of the returned cycler showed no discrepancies.Internal inspection of the pump assembly revealed damage to the front housing and impeller assembly caused by the impeller assembly impacting the front housing.This failure is caused by running the pump motor assembly without water.The observed damage is caused by friction, not burn damage.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.
Additional Manufacturer Narrative
Additional information: d9, g1, h3 plant investigation: the actual device was returned to the manufacturer for physical evaluation.An exterior visual inspection of the returned cycler showed no discrepancies.Internal inspection of the pump assembly revealed damage to the front housing and impeller assembly caused by the impeller assembly impacting the front housing.This failure is caused by running the pump motor assembly without water.The observed damage is caused by friction, not burn damage.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.
Event or Problem Description
A biomedical technician (biomed) at a user facility reported that a fresenius hemodialysis (hd) dry acid mixer had a motor that was not mixing.The field service technician (fst) found a pump head that was burned out.The burned pump head was initially noticed during machine repair for the mixer improperly detecting water inside.The biomed did not observe any burning smell, smoke, spark, flame, arcing, or any other visible heat or electrical damage related to the burning found on the pump head.There was no harm to any patients or individuals because of this malfunction.The biomed reported that the pump is the original fresenius part on the machine and that there was no damage observed on any other components associated with the burned pump head.The biomed replaced the dry level sensor and pump, which resolved the issue.The unit was returned to service at the user facility without issue and without reoccurrence of the event.The pump is available to be returned to the manufacturer 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: 12770114
• Report Number: 2937457-2021-02239
• Device Sequence Number: 14239053
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2021
• Supplement Date Received by Manufacturer: 11/22/2021; 11/22/2021
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 12/16/2021; 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2017
• 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