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 06/25/2019

Event Type  malfunction  

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external inspection of the received device found the usb device¿s strain relief damaged.There are no other discrepancies found externally.The crit-line iv monitor failed to recognize the clic device and the clic device¿s led did not illuminate.The monitor must recognize the device to perform a verify accuracy test or a field calibration.An internal inspection on the clic device found corrosion on the power supply board.There was evidence of an internal short on c104 and d102 of the power supply board.There is also corrosion on the receiver board and under the cover of the clic device.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.

Event Description

A user facility reported that the clic device will not verify.After contacting the customer, it was confirmed that the replacement device was received.This issue was not an out of box failure either as it has been installed on the machine for a duration of time prior to this incident.There was no patient involvement associated with the reported event.Upon physical evaluation of the clic device, an internal short on c104 and c102 of the power supply board was identified.

• 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; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: matthew amaral ; 920 winter st.; waltham, MA 02451 ; 7816999758
• MDR Report Key: 8976378
• MDR Text Key: 156949853
• Report Number: 2937457-2019-02883
• 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
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• 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: 07/12/2019
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 08/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2017
• 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