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 Codes	Thermal Decomposition of Device (1071); Melted (1385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: no parts were 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 or Problem Description
A user facility biomedical technician (biomed) reported that a 2008t machine had a blank display and was giving a constant audible alarm.In addition, the machine would no longer power on.Additional information was provided during follow up with the biomed.The biomed removed the plug from the power outlet and noticed that the plug exhibited signs of heat-related damage.The plastic on the plug had melted and discoloration was observed on the component.Photos of the plug were provided and verified the reported damage.No burning smell was noted.In addition, there were no signs of smoke, sparks, or flames.No damage was identified on any other components.The biomed could not confirm if the machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.However, the biomed didn¿t think the machine had a history of failing the electrical leakage test.Upon further follow up, the biomed reported that replacing the power plug did not resolve the issue.Additional troubleshooting revealed that the user interface board was loose.The biomed reseated the board and was then able to power the machine on.The machine subsequently passed testing and was ready to be returned to service.The biomed inspected the fuses in the power supply and reported they were still in good condition.No sample was available to be returned for evaluation.There was no patient involvement associated with the reported event.

• 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: 10036762
• Report Number: 2937457-2020-00816
• Device Sequence Number: 2614110
• Product Code: KPO
• UDI-Device Identifier: 00840861100927
• UDI-Public: 00840861100927
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 05/07/2020

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?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 05/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1