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	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility biomedical technician (biomed) reported to fresenius technical services that the fill valve of the dry acid mixer smoked upon initiating fill.There were 0 volts of power going to the valve.The biomed was advised to replace the fill valve and control board (and related software).Additional information was obtained during follow-up.The biomed stated that a large amount of white smoke came from the fill valve of the mixer during dissolution mode.The biomed noted that the mixer had also been filling slowly the past few times it had been used.There was no observed spark, flame, or arcing.The facility smoke detectors were not triggered by the smoke from the mixer.A fire extinguisher was not required to address the issue.The biomed stated the smoke dissipated after the machine was powered off and unplugged.There was no harm to any patients or individuals as a result of the reported event.The biomed stated upon examination that the fill valve did not appear to be burned, however there was a slight crack down the side of it and it appeared wet as if from oil but could not be cleaned.Upon testing it was also confirmed that the control board was damaged by the fill valve.A replacement fill valve and control board (as well as software for the control board) were ordered to resolve the reported issue.The samples were reported to be available to be returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Additional Manufacturer Narrative
Additional information: d9, h3 plant investigation: the fill valve was returned to the manufacturer for physical evaluation.An exterior inspection revealed thermal damage to the valve coil and cracks in the casing.The resistance measured across the hot and neutral terminals was found to be shorted.The reported issue is confirmed.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-conformance's, 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.
Event or Problem Description
A user facility biomedical technician (biomed) reported to fresenius technical services that the fill valve of the dry acid mixer smoked upon initiating fill.There were 0 volts of power going to the valve.The biomed was advised to replace the fill valve and control board (and related software).Additional information was obtained during follow-up.The biomed stated that a large amount of white smoke came from the fill valve of the mixer during dissolution mode.The biomed noted that the mixer had also been filling slowly the past few times it had been used.There was no observed spark, flame, or arcing.The facility smoke detectors were not triggered by the smoke from the mixer.A fire extinguisher was not required to address the issue.The biomed stated the smoke dissipated after the machine was powered off and unplugged.There was no harm to any patients or individuals as a result of the reported event.The biomed stated upon examination that the fill valve did not appear to be burned, however there was a slight crack down the side of it and it appeared wet as if from oil but could not be cleaned.Upon testing it was also confirmed that the control board was damaged by the fill valve.A replacement fill valve and control board (as well as software for the control board) were ordered to resolve the reported issue.The samples were reported to be available to be returned to the manufacturer for physical evaluation.

• 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: 19933548
• Report Number: 0002937457-2024-01154
• Device Sequence Number: 2725155
• Product Code: KPO
• UDI-Device Identifier: 00840861100996
• UDI-Public: 00840861100996
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 09/03/2024

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: Other
• Device Catalogue Number: RTL160147
• 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: 07/30/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2021
• 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