MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 190713

Device Problems Thermal Decomposition of Device (1071); Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 01/03/2018

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental medwatch report will be submitted upon completion of this activity.

Event Description

A biomedical engineer (biomed) at a user facility reported that the fresenius 2008t hemodialysis (hd) machine had a burned power control board.The machine had been installed recently at a new dialysis clinic that is currently not yet opened for public business.A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals as a result of this event.The biomed stated that when the machine was first turned on, there was an audible popping noise, burning smell, and visible spark visible through the crack in the back of the machine.Upon further inspection, the biomed found burn marks on the power control board on one of the electrodes.There was no smoke or flame observed.There was no damage observed on any other components.The power control board was the original part on the fresenius machine.The biomed stated that the machine is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The biomed replaced the power control board, which resolved the issue.Following the part replacement, the system was restored to full functionality.The power control board was stated to be available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Device evaluation: there was no on-site evaluation of the unit performed by a fresenius regional equipment specialist (res).The user facility biomedical technician (biomed) replaced the power control board, which resolved the issue.The unit was returned to service at the user facility without a recurrence of the event as reported.The power control board was returned to the manufacturer for physical evaluation.However, the evaluation has not yet been completed.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 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 will be reached following a completed physical examination of the complaint device.

Manufacturer Narrative

Follow-up #2: additional information and device evaluation additional information: device evaluation: the power control board was returned to the manufacturer for analysis.A visual examination was performed on the power control board which revealed signs of heat damage on capacitor c10.There were visible charred marks on the power control board around c10, however, there was no damage observed to the nearby components.Functional testing was performed by installing the received power control board into a working test machine.The power control board, in as-is condition, was able to be installed.The test unit was powered on without any failures.The test unit was able to complete the rinse, self-test, and heat disinfect programs without any failures or alarms.The power control board was repaired by replacing the damaged c10.The repaired board was then subjected to the same functional testing and was installed into a working test unit.All testing passed without any further damage to the power control board.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 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 event.Visual examination of the power control board confirmed that the part sustained heat damage.Therefore, the complaint has been deemed confirmed.

• Brand Name: 2008T HEMODIALYSIS SYS., WITH CDX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 7208960
• MDR Text Key: 98178745
• Report Number: 2937457-2018-00212
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• Combination Product (y/n): N
• PMA/PMN Number: K093902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2018

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 Catalogue Number: 190713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Device Age: MO
• Initial Date Manufacturer Received: 01/03/2018
• Initial Date FDA Received: 01/22/2018
• Supplement Dates Manufacturer Received: 01/26/2018; 03/28/2018
• Supplement Dates FDA Received: 02/14/2018; 04/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1