MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 190713

Device Problems Thermal Decomposition of Device (1071); Melted (1385); Arcing (2583)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2021

Event Type  malfunction  

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).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

A user facility biomedical technician (biomed) reported finding signs of thermal damage during the annual preventive maintenance (pm) check for a fresenius 2008t hemodialysis (hd) machine.The machine was in service mode and the biomed was testing the inlet pressure regulator when they noticed arcing coming from the heater rod.Upon further inspection, they identified evidence of burn damage on the blue wire that connects the heater rod to the distribution board.There was also burnt residue on the distribution board, where the blue wire connects.The biomed stated the blue wire looked like it had melted.In addition, a burning smell was noted.The biomed fixed the machine by replacing the heater rod and distribution board, along with the wires connected to the distribution board (which included the blue wire).There was no sign of any smoke or flames.Per the biomed, the machine had roughly 15,000 miles on it at the time of the event.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.The biomed confirmed the machine was returned to service after the repair.The replaced parts were not available to be returned for evaluation as they were reportedly discarded.Photographs of the wire and the distribution board were provided, and they depicted the component damage as described.There was no patient involvement associated with the reported event.

Manufacturer Narrative

Plant investigation: upon further review by the manufacturing plant, the reported complaint has been confirmed.Although no parts were available for physical evaluation, based on the photographs provided of the wire and distribution board, the reported event was confirmed.

Event Description

A user facility biomedical technician (biomed) reported finding signs of thermal damage during the annual preventive maintenance (pm) check for a fresenius 2008t hemodialysis (hd) machine.The machine was in service mode and the biomed was testing the inlet pressure regulator when they noticed arcing coming from the heater rod.Upon further inspection, they identified evidence of burn damage on the blue wire that connects the heater rod to the distribution board.There was also ¿burnt residue¿ on the distribution board, where the blue wire connects.The biomed stated the blue wire looked like it had melted.In addition, a burning smell was noted.The biomed fixed the machine by replacing the heater rod and distribution board, along with the wires connected to the distribution board (which included the blue wire).There was no sign of any smoke or flames.Per the biomed, the machine had roughly 15,000 miles on it at the time of the event.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.The biomed confirmed the machine was returned to service after the repair.The replaced parts were not available to be returned for evaluation as they were reportedly discarded.Photographs of the wire and the distribution board were provided, and they depicted the component damage as described.There was no patient involvement associated with the reported event.

• Brand Name: 2008T HEMODIALYSIS SYS., WITH CDX
• 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: 11279649
• MDR Text Key: 230291695
• Report Number: 2937457-2021-00188
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• Combination Product (y/n): N
• PMA/PMN Number: K093902
• 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: 04/06/2021

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
• Device Operator: Other
• Device Model Number: 190713
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 01/18/2021
• Initial Date FDA Received: 02/04/2021
• Supplement Dates Manufacturer Received: 03/10/2021
• Supplement Dates FDA Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1