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

Model Number 190766

Device Problems Thermal Decomposition of Device (1071); Melted (1385)

Patient Problem No Patient Involvement (2645)

Event Date 01/21/2020

Event Type  malfunction  

Manufacturer Narrative

This complaint captures one of three events that were reported against the same device, please see associated mdr's (mfr report #'s: 2937457-2020-00271 and 2937457-2020-00272).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 2008t machine was pulled from service due to a valve 104/108 stuck closed message and the machine would not disinfect.During troubleshooting of the machine, the biomed attempted to rebuild the bicarb pump, however the bicarb pump wouldn't calibrate.The bicarb pump was replaced with a new one and it still would not calibrate.At this point, the biomed tried to resolve the issue by replacing the actuator test board.After doing so, a no end of stroke (eos) alarm appeared.Within seconds of installing the replacement actuator test board, a popping sound was heard followed by a burning smell.Upon inspection of the actuator test board, charring was found on the part.A total of three actuator test boards were installed and all three installations resulted in the same popping sounds, burning smell, and visible charring.Each actuator test board exhibited charring in a different location.The third actuator board that was installed displayed evidence of melting on one of the board chips.The biomed stated the electric wiring was assessed and confirmed to be adequate, and reported there was no debris found in the card cage.There were no visible sparks, flames, smoking or arcing.All actuator boards were discarded.The machine remained out of service until a fresenius field service technician (fst) was called onsite.The fst found the eeprom on the function board was not properly seated.The fst reseated the eeprom along with all other modules, one at a time.In addition, the fst replaced the motherboard.These repairs resolved the reported issue.After the repair, the fst performed functional tests on the machine and the machine passed all tests.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 the machine was returned to service and has not experienced any further issues.There was no patient involvement associated with the reported event.This report captures the third of three events that were reported against the same device.

Manufacturer Narrative

Additional information: 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 reseated the eeprom along with all other modules, one at a time, and replaced the motherboard.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 device evaluation, the fresenius fst confirmed evidence of charring and melting on the actuator test board.Therefore, the complaint event was confirmed.

• Brand Name: 2008T HEMODIALYSIS SYSTEM W/BIBAG
• 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: 9690901
• MDR Text Key: 178499947
• Report Number: 2937457-2020-00273
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100910
• UDI-Public: 00840861100910
• Combination Product (y/n): N
• PMA/PMN Number: K121341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 190766
• Device Catalogue Number: 190766
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1