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	05/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The clic crit-line clip device would did not show the led light when it was plugged into a hemodialysis machine.This was determined to be caused by heat damage on the power supply board and the receiver board.The issue was noticed prior to use, and 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 clic device.A verify accuracy test was performed, and the clic device failed to be recognized by the crit-line monitor.During a visual inspection of the clic device, corrosion and heat damage were found on the power supply board and the receiver board.An unknown dried substance was also found on the inside of the receiver housing.The observed corrosion and heat damage to the power supply board will cause the failure of the led to light and the crit-line iv monitor to recognize the clic device.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.
Event or Problem Description
A biomedical technician (biomed) at a user facility reported that clic crit-line clip device would did not show the led light when it was activated.This was determined to be caused by heat damage on the power supply board and the receiver board.The issue was noticed prior to use, and 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 clic device.The biomed replaced the clic device with a new one to resolve the issue.

• 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: 7676849
• Report Number: 2937457-2018-01920
• Device Sequence Number: 13795508
• Product Code: KOC
• UDI-Device Identifier: 00840861101139
• UDI-Public: 00840861101139
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K121599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/11/2018

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 Catalogue Number: CL10041001
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 07/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1