MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HD SYS. CDX W/BIBAG BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 191126

Device Problems Thermal Decomposition of Device (1071); Fire (1245); Melted (1385); Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 08/27/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A hemodialysis (hd) user facility contacted technical support (ts) to request onsite service for a fresenius 2008t hd machine.The machine reportedly ¿caught fire¿.Additional information was obtained via follow-up with a biomedical technician (biomed) from the facility.The biomed stated the event occurred after hours while the machine was in heat disinfect; there was no patient involvement.The biomed was not present during the event; however, the biomed spoke with a technician who witnessed it firsthand.The technician told the biomed that the machine turned off with a ¿power fail¿ alarm, while in heat disinfect.The technician noted a burning smell, and then heard (and saw) a spark come from the outlet that the machine was plugged into.The technician stated the machines power plug then caught on fire.The technician grabbed a fire extinguisher, immediately put out the fire (described as a small flame), and quickly removed the power cord from the outlet.There was no smoke reported, and the smoke detectors did not go off.No treatments were impacted; there were no patients present at the facility.The event left behind burn marks on the power plug and power cord.The power plug looked charred and exhibited signs of melting.The machine was pulled from the floor for evaluation and a fresenius field service technician (fst) was called onsite to inspect it.The fst replaced the power cord and took the damaged one with them when they departed.After the repair was completed, the machine passed functional testing and was deemed ready to be returned to service.During follow-up, the biomed confirmed the machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.It was also confirmed that the machine had no previous history of failing the electrical leakage test.According to the fst¿s service report, the machine had 3,898 hours on it at the time of the repair.It was reported that an electrician came onsite to replace three outlets, which included the outlet this machine was plugged into.The other two outlets were stationed on the same wall.Pictures of the damaged power cord and plug were provided for review.It was unknown if the parts were available to be returned for evaluation.

Manufacturer Narrative

Additional information: h3 plant investigation: no parts were returned to the manufacturer for physical evaluation.However, an on-site evaluation was performed by a fresenius field service technician (fst).To resolve the reported issue, the fst replaced the power cord.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 able to confirm the reported failure mode.During the machine inspection, the fresenius fst confirmed finding thermal damage on the power cord and plug.Therefore, the complaint event was confirmed.

• Brand Name: 2008T HD SYS. CDX W/BIBAG BLUE STAR
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 10558007
• MDR Text Key: 207679469
• Report Number: 2937457-2020-01697
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861102099
• UDI-Public: 00840861102099
• Combination Product (y/n): N
• PMA/PMN Number: K173972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 191126
• Device Catalogue Number: 191126
• Was Device Available for Evaluation?: Yes
• Device Age: MO
• Date Manufacturer Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1