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

Catalog Number	CL10041001
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
Event or Problem Description
A user facility biomedical technician reported clic device blood leak at an unspecified point during a patient¿s hemodialysis (hd) treatment.The blood leak was noted as being observed visually in the clic device after treatment.There was no patient injury, adverse events, or medical intervention required as a result of this event.Additional patient and device information was requested but was not available.The complaint device was reported to be available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Plant investigation: the actual device was returned to the manufacturer for a physical evaluation.An exterior inspection revealed an unknown substance.The verify accuracy tes failed, and the putty system testing failed as well.The 660nm, 830nm, and 1300nm led receiver channel voltage was out of calibration.An internal inspection revealed no discrepancies.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformance's 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.Additional information: added device manufacturing date.

• 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: 7743444
• Report Number: 2937457-2018-02215
• Device Sequence Number: 1366094
• 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: company representative,user f
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2018

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: 08/01/2018
• Device Age: MO
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 08/02/2018
• Supplement Report FDA Received Date: 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1