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	01/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: the sample was returned to the manufacturer for a physical evaluation.An external inspection of the returned sample found no discrepancies.The verify accuracy test was run and failed.The failure was due to the sample unable to power on.The usb cable continuity test was run and passed.During an internal inspection thermal damage was found on power supply board.Fuse f100 was blown.Further investigation found the resistance of fuse f100 to be out of specification.It was concluded that this failure would cause the observed failure of the sample to power on.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, 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.The investigation into the cause of the reported was able to confirm the reported failure mode.
Event or Problem Description
A user facility biomedical technician (biomed) reported to fresenius customer service that a crit-line clip (clic) device would not verify.There was no patient involvement or adverse event reported.The biomed stated the issue was discovered when at the beginning of the day during treatment setup.There is no visible damage to the clic device.The biomed stated during follow-up that a replacement device has been received and the old device has been returned to the manufacturer.Upon physical evaluation of the device by the manufacturer, evidence of blown fuse on the power supply board was identified.
Event or Problem Description
A user facility biomedical technician (biomed) reported to fresenius customer service that a crit-line clip (clic) device would not verify.There was no patient involvement or adverse event reported.The biomed stated the issue was discovered when at the beginning of the day during treatment setup.There is no visible damage to the clic device.The biomed stated during follow-up that a replacement device has been received and the old device has been returned to the manufacturer.Upon physical evaluation of the device by the manufacturer, evidence of blown fuse with thermal damage was identified on the power supply board.

• 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
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 14036172
• Report Number: 2937457-2022-00587
• Device Sequence Number: 4559150
• Product Code: KOC
• UDI-Device Identifier: 00840861101139
• UDI-Public: 00840861101139
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2022

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: 02/24/2022
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic