MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HD SYS. CDX W/BIBAG BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 191126

Device Problems Thermal Decomposition of Device (1071); Fire (1245); Smoking (1585)

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

Event Date 02/15/2023

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 biomedical technician (biomed) at a user facility reported that a fresenius 2008t hemodialysis (hd) machine was smoking from the power supply.The power control board had burnt marks and a capacitor that was completely burnt.The burned board was noticed during machine repair.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 300 hours and the power control board was the original fresenius part on the machine.The field service technician (fst) reported that there was no damage observed on any other components, or any other additional issues, associated with the burned and power control board.The fst replaced the power control board, which resolved the issue.The unit was returned to service at the user facility without issue and without reoccurrence of the event.The power control board was discarded and is not available to be returned to the manufacturer for physical evaluation.

Event Description

A biomedical technician (biomed) at a user facility reported that a fresenius 2008t hemodialysis (hd) machine was smoking from the power supply.The power control board had burnt marks and a capacitor that was completely burnt.The burned board was noticed during machine repair.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 300 hours and the power control board was the original fresenius part on the machine.The field service technician (fst) reported that there was no damage observed on any other components, or any other additional issues, associated with the burned and power control board.The fst replaced the power control board, which resolved the issue.The unit was returned to service at the user facility without issue and without reoccurrence of the event.The power control board was discarded and is not available to be returned to the manufacturer for physical evaluation.Additional information: the machine was brought into the room, plugged in, and powered on.At that point, flames and smoke were seen coming out from the power supply area at the back of the fresenius machine.The power cord was immediately disconnected from the power supply and pushed the hd machine out of the patient's room.The machine continued to catch fire.The flames died down spontaneously after several minutes.A small amount of ashes was observed on the surface of the machine.The engineering department checked the circuit breaker and determined that nothing "tripped".The machine was tagged for investigation.The customer noted that the machine was used for a bedside treatment in icu in the morning without any untoward incident.

Manufacturer Narrative

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

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.However, an on-site evaluation was performed by a fresenius field service technician (fst).To resolve the reported issue, the fst replaced the power control board.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 investigation into the cause of the reported problem was able to confirm the reported failure mode.During the machine inspection, the fresenius fst identified a power control board that had burn marks and a capacitor that was completely burnt.Therefore, the complaint event was confirmed.

Event Description

A biomedical technician (biomed) at a user facility reported that a fresenius 2008t hemodialysis (hd) machine was smoking from the power supply.The power control board had burnt marks and a capacitor that was completely burnt.The burned board was noticed during machine repair.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 346 hours and the power control board was the original fresenius part on the machine.The field service technician (fst) reported that there was no damage observed on any other components, or any other additional issues, associated with the burned and power control board.The fst replaced the power control board, which resolved the issue.The unit was returned to service at the user facility without issue and without reoccurrence of the event.The power control board was discarded and is not available to be returned to the manufacturer for physical evaluation.Additional information: the machine was brought into the room, plugged in, and powered on.At that point, flames and smoke were seen coming out from the power supply area at the back of the fresenius machine.The power cord was immediately disconnected from the power supply and pushed the hd machine out of the patient's room.The machine continued to catch fire.The flames died down spontaneously after several minutes.A small amount of ashes was observed on the surface of the machine.The engineering department checked the circuit breaker and determined that nothing "tripped".The machine was tagged for investigation.The customer noted that the machine was used for a bedside treatment in icu in the morning without any untoward incident.

Manufacturer Narrative

Correction to; b3, b5 (machine hours), g3 (the become aware date on the initial submission was incorrectly reported as 2/18/2023.The correct become aware date should be 2/15/2023.) the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A biomedical technician (biomed) at a user facility reported that a fresenius 2008t hemodialysis (hd) machine was smoking from the power supply.The power control board had burnt marks and a capacitor that was completely burnt.The burned board was noticed during machine repair.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 346 hours and the power control board was the original fresenius part on the machine.The field service technician (fst) reported that there was no damage observed on any other components, or any other additional issues, associated with the burned and power control board.The fst replaced the power control board, which resolved the issue.The unit was returned to service at the user facility without issue and without reoccurrence of the event.The power control board was discarded and is not available to be returned to the manufacturer for physical evaluation.Additional information: the machine was brought into the room, plugged in, and powered on.At that point, flames and smoke were seen coming out from the power supply area at the back of the fresenius machine.The power cord was immediately disconnected from the power supply and pushed the hd machine out of the patient's room.The machine continued to catch fire.The flames died down spontaneously after several minutes.A small amount of ashes was observed on the surface of the machine.The engineering department checked the circuit breaker and determined that nothing "tripped".The machine was tagged for investigation.The customer noted that the machine was used for a bedside treatment in icu in the morning without any untoward incident.

• Brand Name: 2008T HD SYS. CDX W/BIBAG BLUE STAR
• 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: 16443164
• MDR Text Key: 310241512
• Report Number: 0002937457-2023-00288
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861102099
• UDI-Public: 00840861102099
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173972
• 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,Followup,Followup
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 191126
• Device Catalogue Number: 191126
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2022
• 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