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

Catalog Number	CL10041001
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed on the clic device with no physical damage noted.A verify accuracy test was performed and during the test, a crit-line iv monitor failed to recognize the clic device and the device¿s led was not lit.The receiver side of the clic device became hot to the touch after a couple of minutes.During testing, it was determined that inductor l103 on the power supply board became hot to the touch.It is known that if capacitor c219 fails as a short on a clic device¿s transmitter board, additional current will flow through inductor l103 on the power supply board.The additional current through inductor l103 causes the dissipation of additional heat.An internal inspection of the device found an unknown substance inside the transmitter housing, on the transmitter board, and on the clic loop.Capacitor c219 was found to have heat damage on the transmitter board.The issue of a clic device being ¿hot to the touch¿ is being addressed by capa# (b)(4).Upon completion of this evaluation, the reported event is confirmed.
Event or Problem Description
A biomedical technician (biomed) at a user facility reported that a fresenius crit-line clip (clic) device was very hot to the touch when plugged in.During manufacturer failure analysis, heat damage and an unknown substance were noted on the clic device¿s transmitter board.It was confirmed that 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 transmitter board.
Additional Manufacturer Narrative
Additional plant investigation: a serial number search in the ptc complaint system of the clic device¿s serial number found no other complaints with the same symptom code within 90 days of the notification date.

• Brand Name: CRIT-LINE CLIP (CLIC) - USB
• Common Device Name: ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 8161687
• Report Number: 2937457-2018-03665
• Device Sequence Number: 2127156
• Product Code: KOC
• UDI-Device Identifier: 00840861101139
• UDI-Public: 00840861101139
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2018

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 Catalogue Number: CL10041001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Device Age: MO
• Initial Date Received by Manufacturer: 12/07/2018
• Supplement Date Received by Manufacturer: 12/14/2018
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 12/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1