MAUDE Adverse Event Report: CONCORD MANUFACTURING CLM IV MONITOR; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Catalog Number	CL10051001
Medical Device Problem Codes	Fire (1245); Melted (1385); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
Event or Problem 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.
Additional Manufacturer Narrative
A photograph provided by the customer shows the power supply adapter was mounted with the 120-volt connection with the power cord facing upwards.The crit-line iv user¿s guide requires the power supply adapter to be mounted with the ¿attached cable¿ facing upwards (and power cord facing down).This orientation will prevent fluid from seeping in the cavity of the 120-volt connection of the power supply adapter.The user¿s guide also mentions the power supply adapter needs to keep dry to prevent overheating or failure.The crit-line iv monitor, ac adapter cord, and power supply adapter were returned for physical evaluation.The clm iv is covered in soot and part of the rear housing is damaged (melted) from the thermal event.Six ¿known-good¿ clic devices were tested on the returned clm iv.Three clic devices were tested on the front usb port and three were tested on the rear usb port.The returned clm iv functioned properly on all six clic devices without causing any damage to the ¿known-good¿ power cord, power supply adapter, and clic devices.The returned power cord and power supply adapter are melted together and deformed.The resistance across ground and neutral on the power cord found to be shorted and the power cord¿s strain relief is tightly bent and twisted.Due to the severity of the thermal damage, signs of fluid leak could not be visually detected.An internal inspection on the power cord shows no signs of frayed wires at the strain relief.An inspection in the 120-volt connection of the power supply adapter shows a corroded terminal.Due to the severity of the thermal damage, signs of fluid leak could not be visually detected.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.

• Brand Name: CLM IV MONITOR
• 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: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 18498238
• Report Number: 0002937457-2024-00031
• Device Sequence Number: 7950713
• Product Code: KOC
• UDI-Device Identifier: 00840861101122
• UDI-Public: 00840861101122
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K141997
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2024

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 Catalogue Number: CL10051001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2023
• Supplement Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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