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 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation.A visual inspection of the returned device showed no signs of physical damage.There was no power applied to the clic device when it was connected to a crit-line iv monitor.An internal inspection of the clic device found corrosion on the receiver and power supply board.In addition, ic (u300) on the receiver board was shorted and signs of heat damage was found on inductor (l100) on the power supply board.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 reported issue was confirmed and the cause was determined to be physical damage on components of the receiver board and power supply board.The device was returned to returned goods following the evaluation.

Event Description

A user facility biomedical technician (biomed) reported to customer service (cs) that the clic device had no power.A replacement device was issued to the facility.Upon follow-up, the biomed confirmed that the device was previously used.No patient involvement was associated with the reported issue.It was confirmed that the replacement device was received, and the defective device was returned to the manufacturer for evaluation.Upon physical evaluation of the returned device by the manufacturer, evidence of heat damage was found on components located on the receiver board and the power supply board.

• 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: 11497034
• MDR Text Key: 240117636
• Report Number: 2937457-2021-00428
• 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: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CL10041001
• Device Catalogue Number: CL10041001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 03/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2014
• 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