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

Model Number	CRIT-LINE CLIP (CLIC) - USB
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported problems of the clic device ¿overheating¿ and ¿not functioning¿ is confirmed.When connected to a crit-line iv monitor the clic device was not recognized by the monitor, the device¿s red light did not turn on, and the device became hot to the touch.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 inspection of the clic device¿s transmitter board revealed capacitor c219 has burn damage.The failures on the transmitter and power supply boards will cause the observed failures of the clic device¿s led to light and the failure of the clm iv to recognize the clic device.
Event or Problem Description
Biomed technician at a hemodialysis clinic reported that the crit-line clip (clic) - usb device was overheating and not functioning.Follow up with the biomed technician indicated the allegation occurred during treatment.The alleged device was removed from the dialysis machine and it was hot to the touch.Patient treatment continued without interruption or complications.

• 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: 7624898
• Report Number: 2937457-2018-01738
• Device Sequence Number: 16692795
• Product Code: KOC
• UDI-Device Identifier: 00840861101139
• UDI-Public: 00840861101139
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K121599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/21/2018

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: CRIT-LINE CLIP (CLIC) - USB
• Device Catalogue Number: CL10041001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Was the Report Sent to FDA?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2018
• Initial Report FDA Received Date: 06/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1