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

Model Number CL10041001

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2021

Event Type  malfunction  

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 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
• Type of Device: 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: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 11924104
• MDR Text Key: 253846472
• Report Number: 2937457-2021-01156
• Device Sequence Number: 1
• Product Code: KOC
• UDI-Device Identifier: 00840861101139
• UDI-Public: 00840861101139
• Combination Product (y/n): N
• 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
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 05/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1