MAUDE Adverse Event Report: CONCORD MANUFACTURING DRY ACID 132 GALLON UNIT, ASSY TO SHIP; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Catalog Number	RTL160147
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
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¿s biomedical technician (bmt) reported that a fresenius dry acid mixer had thermal damage to the water inlet valve and it¿s cable had moisture in it.A fresenius field service technician (fst) was called onsite and replaced the water inlet valve and cable.The mixer was still not filling, so they replaced the control valve and the 25 gallon sensor to resolve the issue.The dry acid mixer has been returned to service.There was no harm to any patients or individuals because of this malfunction.Multiple attempts have been made to contact the customer to obtain additional information related to the reported event.At this time, no additional information has been provided.Should additional information become available, the file will be updated accordingly.
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 water inlet valve and cable.The mixer was still not filling, so they replaced the control valve and the 25 gallon sensor to resolve the issue.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.
Event or Problem Description
A user facility¿s biomedical technician (bmt) reported that a fresenius dry acid mixer had thermal damage to the water inlet valve and it¿s cable had moisture in it.A fresenius field service technician (fst) was called onsite and replaced the water inlet valve and cable.The mixer was still not filling, so they replaced the control valve and the 25 gallon sensor to resolve the issue.The dry acid mixer has been returned to service.There was no harm to any patients or individuals because of this malfunction.Multiple attempts have been made to contact the customer to obtain additional information related to the reported event.At this time, no additional information has been provided.Should additional information become available, the file will be updated accordingly.
Additional Manufacturer Narrative
Corrected information: h2.The previous submission did not indicate that the type of follow up was for the device evaluation.
Event or Problem Description
A user facility¿s biomedical technician (bmt) reported that a fresenius dry acid mixer had thermal damage to the water inlet valve and it¿s cable had moisture in it.A fresenius field service technician (fst) was called onsite and replaced the water inlet valve and cable.The mixer was still not filling, so they replaced the control valve and the 25 gallon sensor to resolve the issue.The dry acid mixer has been returned to service.There was no harm to any patients or individuals because of this malfunction.Multiple attempts have been made to contact the customer to obtain additional information related to the reported event.At this time, no additional information has been provided.Should additional information become available, the file will be updated accordingly.

• Brand Name: DRY ACID 132 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: 19509703
• Report Number: 0002937457-2024-00885
• Device Sequence Number: 3418503
• Product Code: KPO
• UDI-Device Identifier: 00840861100996
• UDI-Public: 00840861100996
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/14/2024

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 Catalogue Number: RTL160147
• 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: 05/30/2024
• Supplement Date Received by Manufacturer: 06/21/2024; 10/11/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 06/24/2024; 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2023
• 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