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	08/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the clic device passed a verify accuracy test while connected to a crit-line iv monitor.After being connected for several minutes, the transmitter housing became warm to the touch, though the housing did not melt or bubble.An internal inspection of the clic device found corrosion, an unknown substance, and charring on the transmitter board.An unknown substance was found on the inside of the transmitter housing, and on the receiver with the housing removed.The observed corrosion on the transmitter board will cause shorts on the board that can cause the observed charring.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.
Event or Problem Description
A user facility biomedical technician reported a clic device with a burned internal circuit board.The issue was discovered when the clic device became hot to the touch.There were no visible flame, smoke, spark, arcing, or burning smells reported.Upon return to the manufacturer, visible burn damage was discovered on the transmitter board.Due diligence attempts were exhausted, but no additional information was provided.
Additional Manufacturer Narrative
Correction: the prior device evaluation did not include the information from the device history report (dhr).An updated device evaluation will be added.Device evaluation: the clic device passed a verify accuracy test while connected to a crit-line iv monitor.After being connected for several minutes, the transmitter housing became warm to the touch, though the housing did not melt or bubble.An internal inspection of the clic device found corrosion, an unknown substance, and charring on the transmitter board.An unknown substance was found on the inside of the transmitter housing, and on the receiver with the housing removed.The observed corrosion on the transmitter board will cause shorts on the board that can cause the observed charring.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.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformance's, 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.

• 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: 7808470
• Report Number: 2937457-2018-02436
• Device Sequence Number: 1351093
• Product Code: KOC
• UDI-Device Identifier: 00840861101139
• UDI-Public: 00840861101139
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/06/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Device Age: MO
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1