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

Model Number 190858

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 02/01/2021

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 user facility biomedical technician (biomed) reported that the power switch from a fresenius 2008t hemodialysis (hd) machine had failed.The screen would not turn on at the start of the day and the machine was pulled from service for evaluation.During troubleshooting, the biomed noticed that the power switch was not clicking.They unplugged the machine and checked the wire on the switch, which was when the pin came right off.Furthermore, the pin looked charred and blackened.There was no burning smell, smoke, melting, or arcing noted, and there were no reports of sparks or flames.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 stated there were approximately 15,000 hours on the machine at the time of the event.To resolve the reported issue, the biomed replaced the power switch and two fuses on the power logic board.The machine was re-wired and put through testing.The machine passed all testing and was returned to service.The replaced parts were not available to be returned for evaluation as they were reportedly discarded.Photographs of the charred pin were also not available.There was no patient involvement associated with the reported event.

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 that the power switch from a fresenius 2008t hemodialysis (hd) machine had failed.The screen would not turn on at the start of the day and the machine was pulled from service for evaluation.During troubleshooting, the biomed noticed that the power switch was not clicking.They unplugged the machine and checked the wire on the switch, which was when ¿the pin came right off¿.Furthermore, the pin looked charred and blackened.There was no burning smell, smoke, melting, or arcing noted, and there were no reports of sparks or flames.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 stated there were approximately 15,000 hours on the machine at the time of the event.To resolve the reported issue, the biomed replaced the power switch and two fuses on the power logic board.The machine was re-wired and put through testing.The machine passed all testing and was returned to service.The replaced parts were not available to be returned for evaluation as they were reportedly discarded.Photographs of the charred pin were also not available.There was no patient involvement associated with the reported event.

• Brand Name: 2008T HEMODIALYSIS SYSTEM WITHOUT 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: 11309468
• MDR Text Key: 231223960
• Report Number: 2937457-2021-00224
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100903
• UDI-Public: 00840861100903
• Combination Product (y/n): N
• PMA/PMN Number: K113427
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/05/2021

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: 190858
• Device Catalogue Number: 190858
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 02/01/2021
• Initial Date FDA Received: 02/10/2021
• Supplement Dates Manufacturer Received: 02/24/2021
• Supplement Dates FDA Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1