MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 190371

Device Problems Arcing (2583); Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 08/25/2020

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 user facility biomedical technician (biomed) reported that a fresenius 2008k hemodialysis (hd) machine experienced blown fuses during power up.Upon follow-up, it was reported that the issue occurred during a preventive maintenance (pm) check; there was no patient involvement.The blown fuses, which resulted in sparking and arcing, were traced to the machine¿s power control board.According to the biomed, the fuses had blown due to a faulty bridge rectifier.It was reported that part of a fuse enclosure had ¿snapped off¿ the power control board.To resolve the reported issue the biomed replaced both the power control board and the bridge rectifier.There were no burn marks noted on the parts, and there were no signs of charring, melting, smoke, or flames.After completing the repair, the biomed stated the machine was able to power on without issue.At the time of follow up, the machine was still undergoing the pm check.No damage was identified on any other components.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The biomed was unsure if the machine had any previous history of failing the electrical leakage test; however, they stated the power control board was an original (fresenius) part dated from 2003.This led them to believe there haven't been any electrical leakage failures because the power board is typically replaced when electrical leaks are identified.The biomed stated there were 19,737 hours on the machine.The bridge rectifier was discarded.The power control board was available to be returned for evaluation.The biomed stated they would contact technical support to set up returned goods authorization (rga) request.

Manufacturer Narrative

Plant investigation: although a sample was reported to be available for manufacturer evaluation, to date 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.Should the power control board be returned at a later date, a supplemental report will be submitted capturing the updated investigation results.

Manufacturer Narrative

Plant investigation: the power control board was returned to the manufacturer for physical evaluation.No physical damage was identified during a visual inspection of the board.There were no signs of any thermal damage (charring, melting, or arcing).The power control board was installed onto a test machine to test for the reported failure.The test machine was unable to power on with the returned power control board.Further inspection of the board revealed the s12 fuse measured open.The fuse was replaced with a ¿known-good¿ fuse and the test machine was able to power on without any problems.A rinse program was then performed and completed without failures.The machine functioned properly in dialysis mode and passed self-test.Upon completion of the evaluation, the reported issue was confirmed and the cause was traced to the open s12 fuse on the power control board.

• Brand Name: 2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS
• 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: 10544205
• MDR Text Key: 207294169
• Report Number: 2937457-2020-01673
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K994267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 12/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 190371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Device Age: MO
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1