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

Model Number 191130

Device Problems Thermal Decomposition of Device (1071); Arcing (2583)

Patient Problem No Patient Involvement (2645)

Event Date 10/07/2020

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 requested onsite service from a fresenius field service technician (fst) to repair a 2008t machine that was experiencing temperature control issues.The facility was reportedly having trouble increasing the temperature on the machine.The machine was out of service when the fst arrived at the facility, but it was plugged in.After removing the plug from the wall outlet, the fst immediately noticed signs of arcing.They noted evidence of charring stating that it looked like carbon was present in the molded piece of the plug.Upon further investigation, while inspecting the distribution box the fst identified a brown wire on the heater bar that was completely burnt.Based on what they found, the fst thinks the wire was damaged by a current surge that originated at the power plug.The temperature control issue was directly linked to the failed wire connection to the heater bar.The fst cut back the damaged section of the wire, and then resoldered and reconnected it.The fst also replaced the power cord on the machine.After completing the repair work, they power cycled the system multiple times and put the machine through heat disinfect.The temperature control issue was resolved.The machine subsequently passed all functional checks and was put back in service prior to the fst's departure.The damaged power cord/plug was reportedly returned to the manufacturer for evaluation.There was no evidence of any sparks, flames, melting, or burning smell.The machine had 973 hours on it at the time of the repair.No damage was identified on any other components.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet, and there was no previous history of the machine failing the electrical leakage test.There was no patient involvement associated with the reported event.

Manufacturer Narrative

Additional information: device evaluated by mfr? plant investigation: although the power cord was reportedly returned for physical evaluation, to date no parts have been received by the manufacturer.However, an on-site evaluation was performed by a fresenius field service technician (fst).During the fst¿s machine inspection, they identified signs of arcing as thermal damage was present on the power plug and a wire connected to the machine¿s heater bar.To resolve the reported issue, the fst cut back the damaged section and resoldered it in place.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 identified thermal damage on multiple machine parts.Therefore, the complaint event was confirmed.

• Brand Name: 2008T HD SYS. W/O 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: 10738135
• MDR Text Key: 213154867
• Report Number: 2937457-2020-01936
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861102112
• UDI-Public: 00840861102112
• 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: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 191130
• Device Catalogue Number: 191130
• Was Device Available for Evaluation?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 10/26/2020
• Supplement Dates Manufacturer Received: 11/02/2020
• Supplement Dates FDA Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1