MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T GEN 2 BIBAG WITHOUT CDX; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Model Number	190895
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: though they were initially reported to be available for manufacturer evaluation, to date no parts have been received.However, an on-site evaluation was performed by a fresenius field service technician (fst).To resolve the reported issue, the fst replaced the actuator board, the function board, and a function board cable.As a precaution, the flow motor was also replaced.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 device evaluation, the fresenius fst identified burn damage on multiple parts.Therefore, the complaint event was confirmed.
Event or Problem Description
A user facility biomedical technician (biomed) reported to technical support that an audible alarm and a burning smell was coming from a fresenius 2008t hemodialysis (hd) machine.The biomed requested onsite service from a fresenius field service technician (fst).An fst went onsite and performed a machine evaluation.The fst reported finding burn damage during the evaluation.The biomed told the fst that the issue had occurred during heat disinfect.During the fst¿s inspection, they discovered that the driver on the actuator board (which drives the flow motor) displayed burn damage.There was also burn damage on the back of the board.Additionally, burn damage was found on the function board and on one of the function board cables ¿ the cable that runs from the function board to the blood pump.The fst fixed the machine by replacing the actuator board, the function board, and the function board cable.As a precaution, the fst also replaced the flow motor.There was no reported smoke, melting, or arcing noted, and there were no reports of sparks or flames.No damage was identified on any other components.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet, and there was no previous history of the machine failing the electrical leakage test.The fst stated there were 2,744 hours on the machine at the time of the repair.After the repair was completed, the fst sated the machine was returned to service.The replaced parts were available to be returned for evaluation as they were reportedly retained.The fst stated they would set up a returned goods authorization (rga) to have them returned.A photograph, which shows burn damage on the actuator board, was provided.There was no patient involvement associated with the reported event.
Additional Manufacturer Narrative
Additional information: concomitant medical products.Plant investigation: multiple parts were returned to the manufacturer for physical evaluation.The following parts were returned: an actuator test board, a function board, a flow motor, and a blood pump ribbon cable.A visual inspection was performed on the returned parts.Thermal damage was found on the front and back of the actuator test board, at diodes d46 and d47.Diodes d46 and d47 were partially lifted from the board and displayed thermal damage.Further testing of the board could not be performed due to the damage.Thermal debris from the actuator test board was found on the front side of the returned function board.Prior to subsequent testing, the thermal debris was cleaned from the function board using isopropanol alcohol.No discrepancies were found on the returned flow motor.Thermal damage was also found on one of the cables from the returned ribbon cable.The ribbon cable plugs into the function board where the thermal debris from the actuator test board was found.The function board, flow motor, and blood pump ribbon cable were installed on a test machine for functional testing.The self-test program was completed without alarms or failures and no burning smell was detected during the test.No further testing was performed.Upon completion of the investigation, the reported complaint was able to be confirmed.

• Brand Name: 2008T GEN 2 BIBAG WITHOUT CDX
• Common Device Name: DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 10303279
• Report Number: 2937457-2020-01311
• Device Sequence Number: 2577352
• Product Code: KPO
• UDI-Device Identifier: 00840861100927
• UDI-Public: 00840861100927
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K121341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 190895
• Device Catalogue Number: 190895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Device Age: MO
• Initial Date Received by Manufacturer: 07/03/2020
• Supplement Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 07/21/2020
• Supplement Report FDA Received Date: 12/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1