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); Smoking (1585); Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 12/21/2017

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 and discolored power plug.This was observed during inspection of the plug end when the machine was powered on.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 event.The plug was the original fresenius part on the machine.The biomed reported that there was no burning smell; however, there were at least two outlets that had burn damage and there was observed smoke and spark.The machine is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The biomed stated o be ordering a replacement cord and plug assembly.The biomed stated that the machine is currently in service at the user facility with the damaged plug.No parts were stated to be available to be returned to the manufacturer for physical evaluation at this time.

Manufacturer Narrative

Device evaluation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit 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 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.

Event Description

The biomedical engineer (biomed) reportedly received the replacement cord and plug assembly, but had not been able to install it on the machine yet and will plan with the area technical operations manager (atom) a time that the repair can be completed.

Event Description

The biomedical engineer (biomed) was able to replace the power cord on the machine.

• 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: 7181634
• MDR Text Key: 96952420
• Report Number: 2937457-2018-00136
• 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: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 02/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1