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

Catalog Number 190713

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Date 12/12/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A biomedical technician (biomed) at a user facility reported that the 2008t hemodialysis (hd) machine had a burn mark on the power logic board.The machine is in a new facility that is currently not yet open.A patient was not connected to the machine at the time of the incident.When the biomed was attempting to load chairside on the machine, there was an error with the usb.While troubleshooting, the biomed noticed a blackened, burn mark on the backside of the power logic board.No burning smell, smoke, spark, or flame was observed.The machine was evaluated on-site at the user facility by a fresenius regional equipment specialist (res).The res observed evidence of burn damage on the power logic board.The res replaced the power logic board.Following the part replacement, the system was restored to full functionality.The res ordered a new user interface (ui) board for the machine to resolve the usb issue.The ui board was received at the user facility; however, the machine is currently pending the ui board installation.To date, no parts have been made available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer under failure analysis for physical evaluation.The 2008t hemodialysis (hd) machine was evaluated at the facility by the fresenius regional equipment specialist (res).The res observed evidence of burn damage on the power logic board.The res replaced the power logic board.After the repair, machine functional checks were performed, and all tests found the unit to be functioning within specification.The res ordered a new user interface (ui) board for the machine to resolve the usb issue.The ui board was received at the user facility; however, the machine is still pending the ui board installation.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-conformance's or any associated rework 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 failure mode.The res confirmed that burn damage was present on the power logic board.Therefore, the complaint has been deemed confirmed.

Manufacturer Narrative

Type of report: follow-up #2.Additional information and device evaluation: the power logic board was returned to the manufacturer for evaluation.A visual examination was performed on the power logic board which revealed burn damage to pin 14 of header st2.The power supply to power logic board cable connects at power logic board at header st2 and pin 14 is for 24 volts.There were no other damages observed.Functional testing was performed by installing the power logic board into a working unit.The test unit powered on without any alarms or failures.The test unit was able to complete the self-test program without any alarms or failures.The investigation of the returned device further confirmed the reported event.The manufacturer identified visual burn damage to the power logic board.The method/results/conclusion codes remain unchanged from the previous submission.

• Brand Name: 2008T HEMODIALYSIS SYS., WITH CDX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 7150605
• MDR Text Key: 96019662
• Report Number: 2937457-2017-01444
• 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,Followup
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2018
• Device Age: MO
• Date Manufacturer Received: 04/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1