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

Catalog Number 190713

Device Problem Material Discolored (1170)

Patient Problem No Patient Involvement (2645)

Event Date 12/28/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A biomedical engineer (biomed tech) from a user facility reported of a discolored power plug in one of the 2008t machines.The biomed tech stated the issue was detected during maintenance and confirmed there was no patient involvement or injury.The biomed tech stated the plastic at the male end of the plug appeared discolored.No other components were reported to have been discolored nor were any found to be charred, blackened, melted, or have any heat damage.The biomed tech confirmed no visible smoke, flames or sparks were observed, and no damage was observed to the power outlet or machine.The biomed tech confirmed the machine was plugged into a gcfi outlet (hospital grade outlet) as per recommended power source.The power cord was replaced and the machine was placed back in service without further issue.The power cord was available to be returned for evaluation.

Manufacturer Narrative

Plant investigation: the device and component 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

Aa biomedical engineer (biomed tech) from a user facility reported of a discolored power plug in one of the 2008t machines.The biomed tech stated the issue was detected during maintenance and confirmed there was no patient involvement or injury.The biomed tech stated the plastic at the male end of the plug appeared discolored.No other components were reported to have been discolored nor were any found to be charred, blackened, melted, or have any heat damage.The biomed tech confirmed no visible smoke, flames or sparks were observed, and no damage was observed to the power outlet or machine.The biomed tech confirmed the machine was plugged into a gcfi outlet (hospital grade outlet) as per recommended power source.The power cord was replaced and the machine was placed back in service without further issue.The power cord was available to be returned 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
• 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: 7157629
• MDR Text Key: 96371014
• Report Number: 2937457-2018-00010
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093902
• 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: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2011
• 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