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U.S. Department of Health and Human Services

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

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CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
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.
 
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Brand Name2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
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 Key7269807
MDR Text Key100275756
Report Number2937457-2018-00458
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K994267
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 02/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number190610
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 Received02/27/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/03/2010
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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