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U.S. Department of Health and Human Services

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

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CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 190713
Device Problem Material Discolored (1170)
Patient Problem No Patient Involvement (2645)
Event Date 12/28/2017
Event Type  malfunction  
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.
 
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.
 
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Brand Name2008T HEMODIALYSIS SYS., WITH CDX
Type of DeviceDIALYZER, 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 Key7157629
MDR Text Key272919331
Report Number2937457-2018-00010
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093902
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number190713
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received01/08/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/30/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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