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

Model Number CL10051001

Device Problems Thermal Decomposition of Device (1071); Fire (1245); Melted (1385); Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 05/22/2020

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 biomedical equipment specialist (biomed) from a hemodialysis (hd) user facility reported to fresenius technical support (ts) that a crit-line monitor (clm) iv caught on fire.An hd technician reportedly walked into the treatment room and heard an arc (or spark-like) sound.This was immediately followed by the clm catching on fire.The clm was mounted to an intravenous (iv) pole on a b.Braun dialog+ hd machine.The machine was not in use at the time.The technician yelled ¿fire¿ and one of the nurses immediately pulled the fire alarm while another nurse called the emergency line.The technician beat the fire out with a dry towel, unplugged the power supply from the wall, and then removed the clm from the iv pole.The hd technician wanted to get the clm out of the room because it was smoking and patients were still receiving treatment in the room.Once removed from the treatment room, a door was opened to let fresh air in.The hd technician continued to ¿smother¿ the ac adapter and monitor with a dry towel.The biomed responded to the scene and took possession of the device.The device was ¿danger tagged¿ and pulled from service.As a precaution, all other clm¿s were removed from service and danger tagged.Upon evaluation of the damage, it was reported that the clm was burnt on the edges and the device¿s power supply was charred and melted.Additionally, burn marks were visible on the side of the b.Braun hd machine.Additional details were obtained from the biomed during follow up.The biomed stated there were no previous issues with the clm.The power supply adapter that was being used was an original fresenius provided and approved part.At the time of the event, the device was not plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The biomed stated it was possible that the power supply got wet.The biomed also introduced the possibility that the post-treatment cleaning played a part in contributing to the event.The clm was reportedly off when the device caught on fire.It had been 15 to 20 minutes since the device was last in use, and it was confirmed that there was no patient involvement.There was no corrosive buildup noted on any of the electrical connections on the power supply adapter.Prior to the fire, there was no known damage on the power supply adapter.After inspecting the device, the biomed believed that the origin of the fire was the power supply adapter.The event did not impact any ongoing treatments at the facility and it was confirmed that all treatments were completed.There were no reported adverse effects (experienced by patients or staff members) as a result of the reported event.A returned goods authorized (rga) was created to return the damaged monitor and power supply/power cord.

Manufacturer Narrative

Additional information: d10, h3 plant investigation: the customer returned the clm iv monitor and power supply to the manufacturer for physical evaluation.An exterior visual inspection revealed the power supply block was charred and the plastic was warped.The monitor had black soot (a black powdery or flaky substance consisting largely of amorphous carbon, produced by the incomplete burning of organic matter) where the power supply block sits.The clm iv monitor was connected to a known good power supply block and became operational; the monitor moved into the ready screen.Internal inspection of the returned power supply block revealed heavy amounts of soot on the circuit board and the interior case.Upon closer inspection under the microscope at 200 times magnification, pitting was noted on the circuit board caused by corrosion.Internal inspection of the power plug prong and connector revealed corrosion build up in the prong and inside the connector.A review of the device manufacturing records was also 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 traced to the power supply block which exhibited signs of internal thermal damage.

• Brand Name: CLM IV MONITOR
• Type of Device: ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 10138918
• MDR Text Key: 194659926
• Report Number: 2937457-2020-01038
• Device Sequence Number: 1
• Product Code: KOC
• UDI-Device Identifier: 00840861101122
• UDI-Public: 00840861101122
• Combination Product (y/n): N
• PMA/PMN Number: K141997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CL10051001
• Device Catalogue Number: CL10051001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2020
• Device Age: MO
• Date Manufacturer Received: 06/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1