MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number	190610
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2023
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) reported that a fresenius 2008k2 hemodialysis (hd) machine had a burned power plug.The burned power plug was noticed during machine repair.The fst was initially called onsite by the user facility biomedical technician (biomed) when the machine intermittently alarmed in all modes with a 12v high error.A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction.The machine has approximately 22,290 hours and the plug is the original fresenius part on the machine.The biomed reported that there was no melting, burning smell, smoke, spark, flame, or arcing observed.The machine is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The fst replaced the plug to address the power plug discoloration.The fst was unable to duplicate the initial 12v error.However a leak was identified at bicarbonate (bicarb) mixing chamber #2 above the flow motor.Fluid may have been inside the flow motor as it was found to be rusted.The fst determined the wet flow motor caused the intermittent voltage alarms.The bicarb mixing chamber #2, flow motor drive assembly, and flow motor pump head were replaced to resolve the 12v error.The fst reported that the machine has been returned to service without issue.The complaint samples were reported to be discarded and unavailable to be returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.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 manufacturer found during its investigation objective evidence indicating a product problem, thus the complaint is confirmed.
Event or Problem Description
A fresenius field service technician (fst) reported that a fresenius 2008k2 hemodialysis (hd) machine had a burned power plug.The burned power plug was noticed during machine repair.The fst was initially called onsite by the user facility biomedical technician (biomed) when the machine intermittently alarmed in all modes with a 12v high error.A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction.The machine has approximately 22,290 hours and the plug is the original fresenius part on the machine.The biomed reported that there was no melting, burning smell, smoke, spark, flame, or arcing observed.The machine is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The fst replaced the plug to address the power plug discoloration.The fst was unable to duplicate the initial 12v error.However a leak was identified at bicarbonate (bicarb) mixing chamber #2 above the flow motor.Fluid may have been inside the flow motor as it was found to be rusted.The fst determined the wet flow motor caused the intermittent voltage alarms.The bicarb mixing chamber #2, flow motor drive assembly, and flow motor pump head were replaced to resolve the 12v error.The fst reported that the machine has been returned to service without issue.The complaint samples were reported to be discarded and unavailable to be returned to the manufacturer for physical evaluation.

• Brand Name: 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• 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: 17119128
• Report Number: 0002937457-2023-00847
• Device Sequence Number: 17785510
• Product Code: KDI
• UDI-Device Identifier: 00840861100859
• UDI-Public: 00840861100859
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K994267
• 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): 07/03/2023

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: 190610
• Device Catalogue Number: 190610
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2023
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 07/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2009
• 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