MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM WITHOUT CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	190858
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	12/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility biomedical technician (biomed) reported to fresenius technical services that thermal decomposition was identified on the power supply of the 2008t machine.The reported damage was discovered during troubleshooting after the machine was pulled for evaluation for failing to power on.Wires connected to the power supply were dark and discolored.Yellow resistors on the capacitors were burned.There was also evidence of melting.There was no observed burning smell, smoke, spark, flame, arcing, or any other visible heat or electrical damage related to the thermal damage on the power supply.The machine has approximately 21,000 operating hours.It could not be confirmed whether parts were original to the machine.The biomed replaced the power supply assembly, power logic board, motherboard, and front panel keypad (twice).The biomed stated there was power to the machine but the screen remained blank, the machine continuously alarmed and then shut down again after a few minutes.The biomed stated upon follow-up that the machine remains out of service pending repair.There was no patient involvement nor personal harm to any patients or individuals as a result of the reported issue.The samples were 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: although it was stated that the complaint device was available to be returned, to date no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).However the manufacturer confirmed the reported issue based on the provided information.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.
Event or Problem Description
A user facility biomedical technician (biomed) reported to fresenius technical services that thermal decomposition was identified on the power supply of the 2008t machine.The reported damage was discovered during troubleshooting after the machine was pulled for evaluation for failing to power on.Wires connected to the power supply were dark and discolored.Yellow resistors on the capacitors were burned.There was also evidence of melting.There was no observed burning smell, smoke, spark, flame, arcing, or any other visible heat or electrical damage related to the thermal damage on the power supply.The machine has approximately 21,000 operating hours.It could not be confirmed whether parts were original to the machine.The biomed replaced the power supply assembly, power logic board, motherboard, and front panel keypad (twice).The biomed stated there was power to the machine but the screen remained blank, the machine continuously alarmed and then shut down again after a few minutes.The biomed stated upon follow-up that the machine remains out of service pending repair.There was no patient involvement nor personal harm to any patients or individuals as a result of the reported issue.The samples were returned to the manufacturer for physical evaluation.

• Brand Name: 2008T HEMODIALYSIS SYSTEM WITHOUT CDX
• 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: 18393092
• Report Number: 0002937457-2023-01943
• Device Sequence Number: 18334785
• Product Code: KDI
• UDI-Device Identifier: 00840861100903
• UDI-Public: 00840861100903
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K150708
• 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): 01/31/2024

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: 190858
• 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: 12/22/2023
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 12/26/2023
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2015
• 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