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

Catalog Number	160147
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2024
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 fresenius field service technician (fst) was called onsite by a user facility biomedical technician (biomed) to evaluate a dry acid mixer that experienced a fluid leak from the polyvinyl chloride (pvc) pipes.The fst found when the water tank filled during heat disinfection that the high temperature caused the pvc piping to distort and melt.Replacement parts were ordered.A second fst came onsite upon arrival of the parts to complete the repair.The mixer passed functional testing.Additional information was obtained during follow-up with the user facility biomed and facility administrator (fa).The mixer remained out of service until the repair was completed.Jugs were manually filled while the machine remained out of use.There was no observed burning smell, smoke, spark, flame, or arcing.There was no personal harm to any patients or individuals as a result of the malfunction.It was confirmed that the machine is plugged into a hospital-grade ground-fault circuit interrupter (gfci) outlet.The parts were discarded and are not available to be returned to the manufacturer for physical evaluation.
Event or Problem Description
A fresenius field service technician (fst) was called onsite by a user facility biomedical technician (biomed) to evaluate a dry acid mixer that experienced a fluid leak from the polyvinyl chloride (pvc) pipes.The fst found when the water tank filled during heat disinfection that the high temperature caused the pvc piping to distort and melt.Replacement parts were ordered.A second fst came onsite upon arrival of the parts to complete the repair.The mixer passed functional testing.Additional information was obtained during follow-up with the user facility biomed and facility administrator (fa).The mixer remained out of service until the repair was completed.Jugs were manually filled while the machine remained out of use.There was no observed burning smell, smoke, spark, flame, or arcing.There was no personal harm to any patients or individuals as a result of the malfunction.It was confirmed that the machine is plugged into a hospital-grade ground-fault circuit interrupter (gfci) outlet.The parts were discarded and are not available to be returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.However the complaint investigation found objective evidence indicating a product problem, thus the complaint 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-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.

• 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: 18758774
• Report Number: 0002937457-2024-00304
• Device Sequence Number: 6271346
• Product Code: KPO
• UDI-Device Identifier: 00840861100996
• UDI-Public: 00840861100996
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2024

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: 160147
• Was Device Available for Evaluation?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2024
• Supplement Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2023
• 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