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); Smoking (1585); Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 05/13/2020

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 they have replaced the acid pump and the actuator-test board twice and they burned up when the machine was plugged in.At that point in time, the fresenius technical support representative advised the biomed to swap the motherboard, actuator cable, and advised it could be a possible distribution board issue.Upon follow-up, the biomed stated that there were indications of a burning smell, smoke, and sparking.The biomed confirmed that the smoke detectors at the facility did not alarm.The issue was discovered during normal inspection.The machine has approximately 4,200 hours and actuator board is the original fresenius part.There were no past problems with the machine failing the electrical leakage test.The biomed stated that that a wire was damaged when the board was removed because it was caught on a screw which is believed to be the reason for the thermal event.The biomed stated that the machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The biomed confirmed that the actuator board has been replaced and the damaged wire cable was spliced back to rectify the issue.The machine is back in service without reoccurrence of the reported event.The biomed confirmed a patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction.The complaint device is not available to be returned to the manufacturer for physical evaluation because it was discarded.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius regional equipment specialist (res).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: 10102830
• MDR Text Key: 192996575
• Report Number: 2937457-2020-00960
• 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: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• 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
• Date Manufacturer Received: 06/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1