MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 190610

Device Problems Thermal Decomposition of Device (1071); Fire (1245); Smoking (1585); Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 01/16/2020

Event Type  malfunction  

Manufacturer Narrative

This complaint captures one of two events that were reported against the same device, please see associated mdr (mfr report #: 2937457-2020-00249).The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A biomedical technician (biomed) was performing a semi-annual preventive maintenance (pm) check on a fresenius 2008k2 hemodialysis (hd) machine when an ¿acid pump no end of stroke (eos)¿ message was displayed.The message was displayed on power up.The biomed stated there was a burning smell that followed.The biomed shut down the machine and attempted to locate the origin of the burning smell; nothing could be found.The biomed then replaced the acid pump which failed to resolve the reported issue; the no eos message continued to appear.The biomed then replaced the actuator test board with a brand new one.After replacing the actuator test board, the biomed powered up the machine with the card cage open to have visibility of the board.When the machine was moved into rinse mode, a spark was observed coming from the actuator test board, followed by a small flame that extinguished within a second, and then a small cloud of smoke.The smoke detectors did not go off.The biomed removed the second actuator board to inspect it for damage, and burn marks were noted on the ic19 and ic23 chips.The biomed then looked at the first actuator test board and verified that there were burn marks on the same chips.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.Upon follow up with the biomed, it was confirmed that there was no patient involvement associated with the reported events.The machine remains out of service as the biomed is waiting on a replacement actuator board for installation.It was also reported that the biomed only visits the clinic once a quarter.The actuator test boards are reportedly available for evaluation, and the biomed intends to send them back to the manufacturer.This report captures the spark, small flame, and cloud of smoke that came from the second actuator test board, in addition to burn marks on the board.

Manufacturer Narrative

Plant investigation: although it was stated that the complaint device was available to be returned, to date no parts have been 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.

• Brand Name: 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
• 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: 9673432
• MDR Text Key: 177865453
• Report Number: 2937457-2020-00250
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100859
• UDI-Public: 00840861100859
• 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
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 190610
• Device Catalogue Number: 190610
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 01/16/2020
• Initial Date FDA Received: 02/05/2020
• Supplement Dates Manufacturer Received: 02/12/2020
• Supplement Dates FDA Received: 02/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1