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

Catalog Number 190713

Device Problems Thermal Decomposition of Device (1071); Fire (1245)

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

Event Date 02/28/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A user facility biomedical technician (biomed) reported to fresenius technical services that the actuator board of the 2008t machine caught fire.There was no patient involvement regarding the reported event.The machine also displayed the actuator board no echo message and provided an audible alarm.The biomed confirmed the reported product complaint during follow-up and provided additional information.The biomed stated that semi-annual preventative maintenance was being performed on the 2008t machine when the reported issue occurred.The biomed stated that upon powering on the machine a burning smell was observed coming from the card cage.Upon inspection it was discovered that the actuator board had caught fire.A flame was visually observed coming from the board.The machine was powered down to extinguish the flame.There was no observed smoke, spark, or arcing.The facility smoke detectors were not triggered.Use of a fire extinguisher was not required.The biomed noted a burn mark to the actuator board after the flame was extinguished.The biomed confirmed the board is original to the machine.The machine has approximately 17,000 operating hours.The biomed stated that the actuator board was replaced, which resolved the machine issue, and that the machine is back in service without any issues.Additionally, the biomed confirmed that there was no damage observed on any other components, or any other additional issues, associated with the burned actuator board.The biomed confirmed that 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 biomed confirmed that the actuator board and ribbon cable were returned to the manufacturer for physical evaluation.

Event Description

A user facility biomedical technician (biomed) reported to fresenius technical services that the actuator board of the 2008t machine caught fire.There was no patient involvement regarding the reported event.The machine also displayed the actuator board no echo message and provided an audible alarm.The biomed confirmed the reported product complaint during follow-up and provided additional information.The biomed stated that semi-annual preventative maintenance was being performed on the 2008t machine when the reported issue occurred.The biomed stated that upon powering on the machine a burning smell was observed coming from the card cage.Upon inspection it was discovered that the actuator board had caught fire.A flame was visually observed coming from the board.The machine was powered down to extinguish the flame.There was no observed smoke, spark, or arcing.The facility smoke detectors were not triggered.Use of a fire extinguisher was not required.The biomed noted a burn mark to the actuator board after the flame was extinguished.The biomed confirmed the board is original to the machine.The machine has approximately 17,000 operating hours.The biomed stated that the actuator board was replaced, which resolved the machine issue, and that the machine is back in service without any issues.Additionally, the biomed confirmed that there was no damage observed on any other components, or any other additional issues, associated with the burned actuator board.The biomed confirmed that 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 biomed confirmed that the actuator board and ribbon cable were returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Additional information: b3 the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Manufacturer Narrative

Additional information: b3 the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

A user facility biomedical technician (biomed) reported to fresenius technical services that the actuator board of the 2008t machine caught fire.There was no patient involvement regarding the reported event.The machine also displayed the actuator board no echo message and provided an audible alarm.The biomed confirmed the reported product complaint during follow-up and provided additional information.The biomed stated that semi-annual preventative maintenance was being performed on the 2008t machine when the reported issue occurred.The biomed stated that upon powering on the machine a burning smell was observed coming from the card cage.Upon inspection it was discovered that the actuator board had caught fire.A flame was visually observed coming from the board.The machine was powered down to extinguish the flame.There was no observed smoke, spark, or arcing.The facility smoke detectors were not triggered.Use of a fire extinguisher was not required.The biomed noted a burn mark to the actuator board after the flame was extinguished.The biomed confirmed the board is original to the machine.The machine has approximately 17,000 operating hours.The biomed stated that the actuator board was replaced, which resolved the machine issue, and that the machine is back in service without any issues.Additionally, the biomed confirmed that there was no damage observed on any other components, or any other additional issues, associated with the burned actuator board.The biomed confirmed that 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 biomed confirmed that the actuator board and ribbon cable were returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Additional information: d9, h3 plant investigation: the actuator test board and cable were returned to the manufacturer for physical evaluation.The actuator/test board was received with thermal damage to capacitor c143 and damage to ic26.There is thermal damage on the back of the board behind c143 location.There are no other signs of damage on the actuator/test board.The actuator/test board was installed onto a test machine for testing.A thermal event occurred on the returned actuator/test board during power up (fire, smoke, and burning smell was observed).The test machine was powered off.The thermal event occurred at capacitor c143, further damaging ic26 and damaging diode d19.The thermal event caused board damage and lift traces around c143 area.The actuator/test board is not repairable.The actuator cable was received with debris(soot) from the damaged actuator/test board.A detailed inspection found no exposed or damaged wires.The returned actuator cable was tested with a ¿known-good¿ actuator/test board.There were no problems during power up.The rinse program completed without problems.Dialysis mode functioned properly without any failures.The self-test program completed without any failures.The actuator cable functioned properly during testing.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: 2008T HEMODIALYSIS SYS., WITH 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: 18885778
• MDR Text Key: 337435725
• Report Number: 0002937457-2024-00424
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 04/02/2024

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: 190713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 03/12/2024
• Supplement Dates Manufacturer Received: 03/12/2024; 04/01/2024
• Supplement Dates FDA Received: 03/12/2024; 04/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2013
• 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