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 Charred (1086); Melted (1385)

Patient Problem No Patient Involvement (2645)

Event Date 12/14/2017

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 discolored power plug which was observed during preventative maintenance or servicing the machine unrelated to the plug.The inside of the plastic casing of the plug was reportedly melted and charred.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 biomed reported that there was no smoke, spark or flame observed.The biomed replaced the power plug assembly, which resolved the issue.The unit was returned to service at the user facility without a recurrence of the event as reported.No parts are available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Plant investigation: 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).The reported melted and charred power plug was replaced by the biomedical technician (biomed) to resolve the issue.Following parts replacement, the unit was returned to service at the user facility without a recurrence of the event as reported.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.

• 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: 7164271
• MDR Text Key: 96490196
• Report Number: 2937457-2018-00064
• 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
• Report Date: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• 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: 01/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1