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

Catalog Number 190858

Device Problems Thermal Decomposition of Device (1071); Melted (1385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2023

Event Type  malfunction  

Event 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.

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

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 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
• Type of Device: 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
• MDR Text Key: 331312306
• Report Number: 0002937457-2023-01943
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100903
• UDI-Public: 00840861100903
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150708
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 190858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 12/22/2023
• Initial Date FDA Received: 12/26/2023
• Supplement Dates Manufacturer Received: 01/31/2024
• Supplement Dates FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1