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

A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A biomedical engineer (biomed tech) reported a discolored hemodialysis machine power plug.There were no diagnostic messages or audible alarms expected, and there was no problem with the machine.The biomed tech stated he found the discolored plug while performing preventative maintenance or servicing unrelated to the plug.The biomed tech stated that the issue has been resolved, the device is in service, and confirmed that there was no patient involvement.The inside of the plastic casing of each plug showed melting and charring.No spark, smoke, or flame from the plug was noticed.The sample was discarded and was no longer available for evaluation.

Manufacturer Narrative

Plant investigation: the device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.All device history records (dhr) are reviewed and released according to the dhr review checklist and release procedure.A device is not released if it does not meet requirements or is nonconforming.In addition, the device record review confirmed the labeling, material, and process controls were within specification.

Event Description

A biomedical engineer (biomed tech) reported a discolored hemodialysis machine power plug.There were no diagnostic messages or audible alarms expected, and there was no problem with the machine.The biomed tech stated he found the discolored plug while performing preventative maintenance or servicing unrelated to the plug.The biomed tech stated that the issue has been resolved, the device is in service, and confirmed that there was no patient involvement.The inside of the plastic casing of each plug showed melting and charring.No spark, smoke, or flame from the plug was noticed.The sample was discarded and was no longer available for evaluation.

• 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: 7161085
• MDR Text Key: 96393763
• Report Number: 2937457-2018-00031
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• 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: 01/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1