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

Catalog Number 190766

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

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

Event Date 08/29/2023

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 user facility biomedical technician (biomed) reported to fresenius technical services that a 2008t machine had a burned bibag interface board.The reported issue was discovered during troubleshooting.The machine was initially pulled from service when the machine would not power on.A blank display and a constant audible alarm were received.The motherboard and display assembly were replaced.Upon powering the machine back on a flash was observed coming from the bibag interface board and the burnt board was discovered.Additional information was obtained during follow-up with the biomed.The biomed stated that corrosion was also identified on the motherboard from bleach damage and was replaced along with the display assembly to address the power and display issues.The biomed powered the machine on and a flame appeared inside the card cage during the boot sequence.The biomed powered the machine down to put out the flame.The flame extinguished into smoke which dissipated.The facility smoke detectors were not triggered by the flame or smoke nor was a smoke extinguisher required to address the damage.The biomed determined the source of the flame to be the bibag interface board which also appeared to be burned.The biomed stated that the machine has approximately 27,000 hours.The biomed could not confirm whether the part was original to the fresenius machine but confirmed the part had not been replaced in the past year.The biomed stated that the bibag interface board was replaced to resolve the thermal damage 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 bibag interface 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 bibag interface board is available for return to the manufacturer for physical evaluation.

Manufacturer Narrative

Additional information: d9, h3 plant investigation: the bibag interface board was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).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 not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

Event Description

A user facility biomedical technician (biomed) reported to fresenius technical services that a 2008t machine had a burned bibag interface board.The reported issue was discovered during troubleshooting.The machine was intiailly pulled from service when the machine would not power on.A blank display and a constant audible alarm were received.The motherboard and display assembly were replaced.Upon powering the machine back on a flash was observed coming from the bibag interface board and the burnt board was discovered.Additional information was obtained during follow-up with the biomed.The biomed stated that corrosion was also identified on the motherboard from bleach damage and was replaced along with the display assembly to address the power and display issues.The biomed powered the machine on and a flame appeared inside the card cage during the boot sequence.The biomed powered the machine down to put out the flame.The flame extinguished into smoke which dissipated.The facility smoke detectors were not triggered by the flame or smoke nor was a smoke extinguisher required to address the damage.The biomed determined the source of the flame to be the bibag interface board which also appeared to be burned.The biomed stated that the machine has approximately (b)(4).The biomed could not confirm whether the part was original to the fresenius machine but confirmed the part had not been replaced in the past year.The biomed stated that the bibag interface board was replaced to resolve the thermal damage 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 bibag interface 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 bibag interface board is available for return to the manufacturer for physical evaluation.

Event Description

A user facility biomedical technician (biomed) reported to fresenius technical services that a 2008t machine had a burned bibag interface board.The reported issue was discovered during troubleshooting.The machine was initially pulled from service when the machine would not power on.A blank display and a constant audible alarm were received.The motherboard and display assembly were replaced.Upon powering the machine back on a flash was observed coming from the bibag interface board and the burnt board was discovered.Additional information was obtained during follow-up with the biomed.The biomed stated that corrosion was also identified on the motherboard from bleach damage and was replaced along with the display assembly to address the power and display issues.The biomed powered the machine on and a flame appeared inside the card cage during the boot sequence.The biomed powered the machine down to put out the flame.The flame extinguished into smoke which dissipated.The facility smoke detectors were not triggered by the flame or smoke nor was a smoke extinguisher required to address the damage.The biomed determined the source of the flame to be the bibag interface board which also appeared to be burned.The biomed stated that the machine has approximately (b)(4) hours.The biomed could not confirm whether the part was original to the fresenius machine but confirmed the part had not been replaced in the past year.The biomed stated that the bibag interface board was replaced to resolve the thermal damage 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 bibag interface 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 bibag interface board is available for return to the manufacturer for physical evaluation.

Manufacturer Narrative

Additional information: d9, h3 plant investigation: the bibag interface board was returned to the manufacturer for physical evaluation.The board was returned with thermal damage to capacitor c63.There is no damage to any nearby components on the board.The board was installed (in as-received condition) onto test machine for testing.A rinse program was completed without any failures.Dialysis mode functioned properly without any failures.Self-test program completed without any failures.The bibag fill and empty program was performed without failures.The bibag gen2 board functioned properly despite of the damage capacitor c63.The reported issue was confirmed.

• Brand Name: 2008T HEMODIALYSIS SYSTEM W/BIBAG
• 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: 17664292
• MDR Text Key: 322432070
• Report Number: 0002937457-2023-01335
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100910
• UDI-Public: 00840861100910
• 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,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 190766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 08/29/2023
• Initial Date FDA Received: 08/31/2023
• Supplement Dates Manufacturer Received: 10/06/2023; 10/19/2023
• Supplement Dates FDA Received: 10/09/2023; 10/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2016
• 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