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

Catalog Number CL10041001

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Date 10/18/2018

Event Type  malfunction  

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 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.

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
• Type of Device: ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 8161687
• MDR Text Key: 130252647
• Report Number: 2937457-2018-03665
• Device Sequence Number: 1
• Product Code: KOC
• UDI-Device Identifier: 00840861101139
• UDI-Public: 00840861101139
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121599
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CL10041001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 12/13/2018
• Supplement Dates Manufacturer Received: 12/14/2018
• Supplement Dates FDA Received: 12/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1