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

Catalog Number CL10041001

Device Problems Fire (1245); Melted (1385); Smoking (1585)

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

Event Date 12/28/2023

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

The hospital safety quality specialist reported to fresenius that the crit-line clip (clic) device caught fire while connected to the power adapter of the clm iv monitor.There was no patient involvement regarding the reported event.No patients or individuals were harmed.The machine was plugged in but not powered on or actively in use when the reported event occurred.Additional information was obtained during follow-up.A nurse returned to the unit and visually observed a smoking flame.Unplugging the monitor from the wall outlet extinguished the fire.No smoke detectors within the facility were triggered.Use of a fire extinguisher was not required.It was noted that the clic device was plugged into the top plug of the battery pack and had melted.No issues were found with the wall outlet.No repairs were made to the products.The products have been returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Plant investigation: the device was not returned to the manufacturer which prevented a physical evaluation from being performed.A photograph of the reported issue was provided however a clic device was not pictured.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 problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

Event Description

The hospital safety quality specialist reported to fresenius that the crit-line clip (clic) device caught fire while connected to the power adapter of the clm iv monitor.There was no patient involvement regarding the reported event.No patients or individuals were harmed.The machine was plugged in but not powered on or actively in use when the reported event occurred.Additional information was obtained during follow-up.A nurse returned to the unit and visually observed a smoking flame.Unplugging the monitor from the wall outlet extinguished the fire.No smoke detectors within the facility were triggered.Use of a fire extinguisher was not required.It was noted that the clic device was plugged into the top plug of the battery pack and had melted.No issues were found with the wall outlet.No repairs were made to the products.The products have been returned to the manufacturer for physical evaluation.

• 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: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 18498215
• MDR Text Key: 332702668
• Report Number: 0002937457-2024-00062
• 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: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CL10041001
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2021
• 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