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); Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/24/2021

Event Type  malfunction  

Manufacturer Narrative

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 ui/mics board.In addition, a photo of the thermal damage was provided for review.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 a burnt component on the ui/mics board and a photo of the damage was provided as objective evidence.Therefore, the complaint event was confirmed.

Event Description

A user facility biomedical technician (biomed) reported that the screen of a fresenius 2008t hemodialysis (hd) machine went blank during a patients treatment and the staff could not get the screen to reilluminate.The patient was moved to another machine where they completed their treatment, and the machine was pulled from service for evaluation.There was no blood loss as the patients blood was returned prior to being moved.The were no adverse effects experienced by the patient and there was no medical intervention required due to the reported event.The clinical staff told the biomed that there were no machine alarms during the treatment.The biomed began troubleshooting the issue, and while the card cage was open they noticed a burning smell and a tiny puff of smoke.The biomed contacted fresenius and a field service technician (fst) was dispatched to the site.Together, the biomed and fst were able to locate the source of the burning smell and smoke.The source was found to be the ui/mics board.A photo of a burnt component on the corner of the board was provided for review.The ui/mics board was replaced to resolve the issue.No damage was identified on any other parts.There were no flames or sparks.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet and had no previous history of failing the electrical leakage test.The biomed stated there were approximately 18,500 hours on the machine.After replacing the board, the machine passed all functional testing and was deemed available to be returned to service.The damaged ui/mics board was not available for evaluation as the part was reportedly discarded.The biomed was unable to provide patient information.

• 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
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 11992515
• MDR Text Key: 255980101
• Report Number: 2937457-2021-01242
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/14/2021

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 05/25/2021
• Initial Date FDA Received: 06/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1