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

Model Number	CL10041001
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: the actual device was returned to the manufacturer for physical evaluation.During an external visual inspection of the device a dried substance was found on the transmitter cover.A verify accuracy test was performed and failed.The clic device was then attached to a monitor which failed to recognize it and the clic devices red light did not illuminate.A usb cable continuity test was performed and passed.An internal inspection revealed corrosion and thermal damage to the transmitter board and to the inside of the transmitter cover.An internal visual inspection of the returned cycler encountered no other discrepancies.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.Upon completion of the evaluation, the customer's reported issue of the clic's failure to verify was confirmed.
Event or Problem Description
A user facility biomedical technician (biomed) reported to fresenius customer service that the crit-line clip (clic) device would not verify.There was no patient involvement associated with the reported event.Additional information was requested, however to date a response has not been received.The clic device was returned to the manufacturer for physical evaluation.An internal inspection of the clic device revealed corrosion and thermal damage to the transmitter board and to the inside of the transmitter cover.

• Brand Name: CRIT-LINE CLIP (CLIC) - USB
• Common Device Name: ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 11924104
• Report Number: 2937457-2021-01156
• Device Sequence Number: 845388
• Product Code: KOC
• UDI-Device Identifier: 00840861101139
• UDI-Public: 00840861101139
• Combination Product (Y/N): N
• Initial Reporter State: ME
• PMA/510(K) Number: K121599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 06/02/2021

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: CL10041001
• Device Catalogue Number: CL10041001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1