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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.¿.
Event or Problem Description
A biomedical technician (biomed) at a user facility reported that brushes on the deaeration motor of a fresenius 2008t hemodialysis (hd) machine were burned.The burned brushes were noticed during machine repair after the machine alarmed with a flow inlet error.The biomed stated that they did not observe any burning smell, smoke, spark, flame, arcing, or any other visible heat or electrical damage related to the burning on the deaeration motor.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 reported that there was no damage observed on any other components, or any other additional issues, associated with the burned brushes.The biomed stated at the time of followup that the machine will remain out of service until the arrival of a replacement deaeration motor.The complaint device is available to be returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.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.A technical support call took place between the customer and a fresenius field service technician (fst) during the evaluation of the machine and the reported burn damage was able to be confirmed.
Event or Problem Description
A biomedical technician (biomed) at a user facility reported that brushes on the deaeration motor of a fresenius 2008t hemodialysis (hd) machine were burned.The burned brushes were noticed during machine repair after the machine alarmed with a flow inlet error.The biomed stated that they did not observe any burning smell, smoke, spark, flame, arcing, or any other visible heat or electrical damage related to the burning on the deaeration motor.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 reported that there was no damage observed on any other components, or any other additional issues, associated with the burned brushes.The biomed stated at the time of followup that the machine will remain out of service until the arrival of a replacement deaeration motor.The complaint device is available to be returned to the manufacturer for physical evaluation.

• 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: 12153511
• Report Number: 2937457-2021-01444
• Device Sequence Number: 4777362
• Product Code: KPO
• UDI-Device Identifier: 00840861100927
• UDI-Public: 00840861100927
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K121341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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
• Operator of Device: Health Professional
• Device Model Number: 190895
• Device Catalogue Number: 190895
• Was Device Available for Evaluation?: Yes
• Device Age: MO
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 07/12/2021
• Supplement Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1