MAUDE Adverse Event Report: CONCORD MANUFACTURING CRIT-LINE CLIP (CLIC) - USB; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Model Number	CL10041001
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
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
Event or Problem Description
A user facility biomed technician (biomed) requested a part number for the function board on the 2008t machine.The biomed technician reported issues with the p41 cable ground post getting a burnt spot.In addition, the side usb port is exposed when the clic is not connected.The fresenius technical support representative provided the requested part number, and advised the biomed technician to have the side usb cover/flap closed when the port is not in use.The biomed technician was informed that fluid may be getting in the port when the machine is wiped down, resulting in an issue near the p41 connection.Upon follow-up with the biomed, it was reported that the function board had a burn spot due to a short.It was reported that the crit line cable wiring caused the short/burn spot on the board.The biomed confirmed that there was no burning smell, melting, smoke, spark, or flame, only that it appeared to be discolored and burned.There was no other physical damage on the board itself.The issue was noted during normal repair.The machine had no past problems failing the electrical leakage test and there were no other damaged components noted.The machine was not plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The crit line plug/cables and function board were replaced which resolved the issue, but it was reported the machine is not yet back in service.There was no patient involvement, and no harm occurred to any other individuals as a result of the reported issue.It was reported that the defective parts are available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Additional information: h3 plant investigation: although it was stated that the complaint device was available to be returned, to date no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius regional equipment specialist (res).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.

• Brand Name: CRIT-LINE CLIP (CLIC) - USB
• Common Device Name: ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 10273257
• Report Number: 2937457-2020-01271
• Device Sequence Number: 3399340
• Product Code: KOC
• UDI-Device Identifier: 00840861101139
• UDI-Public: 00840861101139
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K121599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CL10041001
• Device Catalogue Number: CL10041001
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 06/26/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1