MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 190610

Device Problem Material Discolored (1170)

Patient Problem No Patient Involvement (2645)

Event Date 01/31/2018

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 there was brown discoloration on a 2008k2 hemodialysis machine power cord plug.Stated the prongs on the power cord were fine; however, the power cord was discolored.This was found while doing an afterhours inspection.The biomed tech described the power code plug was "brownish" and stated only the plug was brown, the prongs were free of discoloration.The biomed tech denied the power cord was charred, blackened, melted or burned and there were no other components involved, nor were any observed to have received any heat damage.There was no burn smell, smoke, and/or spark/flame.The power cord was the original cord and was plugged into gcfi outlet.The power cord was available for return.

Manufacturer Narrative

Plant investigation: the device or component were 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-conformance's 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 there was brown discoloration on a 2008k2 hemodialysis machine power cord plug.Stated the prongs on the power cord were fine; however, the power cord was discolored.This was found while doing an after hours inspection.The biomed tech described the power code plug was "brownish" and stated only the plug was brown, the prongs were free of discoloration.The biomed tech denied the power cord was charred, blackened, melted or burned and there were no other components involved, nor were any observed to have received any heat damage.There was no burn smell, smoke, and/or spark/flame.The power cord was the original cord and was plugged into gcfi outlet.The power cord was available for return.

• 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; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 7269807
• MDR Text Key: 100275756
• Report Number: 2937457-2018-00458
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100859
• UDI-Public: 00840861100859
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 190610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 02/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1