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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 Thermal Decomposition of Device (1071)
Patient Problem No Patient Involvement (2645)
Event Date 12/21/2017
Event Type  malfunction  
Manufacturer Narrative
A supplemental medwatch report will be submitted upon completion of the investigation.
 
Event Description
A user facility biomedical engineer (biomed tech) reported a discolored power cord plug and confirmed there was no patient involvement and no injury occurred.The biomed tech stated he was requested to perform an inspection on the machine and noted the power cord appeared discolored and burnt at the plug.The biomed tech stated the discovered power cord was replaced and confirmed no smoke or visible flames were reported from the power plug.The biomed tech the machine functioned as intended prior to the observation.No damage to the machine or receptacle was noted, and no burning smell, smoke or visible flame was reported as a result of the reported damaged power cord.The biomed tech stated the power plug was replaced as a precaution and the machine was placed back in service without any further issue.The power cord was available to be returned for evaluation.The machine serial number was to be provided by the biomed tech.
 
Event Description
A user facility biomedical engineer (biomed tech) reported a discolored power cord plug and confirmed there was no patient involvement and no injury occurred.The biomed tech stated he was requested to perform an inspection on the machine and noted the power cord appeared discolored and burnt at the plug.The biomed tech stated the discovered power cord was replaced and confirmed no smoke or visible flames were reported from the power plug.The biomed tech the machine functioned as intended prior to the observation.No damage to the machine or receptacle was noted, and no burning smell, smoke or visible flame was reported as a result of the reported damaged power cord.The biomed tech stated the power plug was replaced as a precaution and the machine was placed back in service without any further issue.The power cord was available to be returned for evaluation.The machine serial number was to be provided by the biomed tech.
 
Event Description
A user facility biomedical engineer (biomed tech) reported a discolored power cord plug and confirmed there was no patient involvement and no injury occurred.The biomed tech stated he was requested to perform an inspection on the machine and noted the power cord appeared discolored and burnt at the plug.The biomed tech stated the discovered power cord was replaced and confirmed no smoke or visible flames were reported from the power plug.The biomed tech the machine functioned as intended prior to the observation.No damage to the machine or receptacle was noted, and no burning smell, smoke or visible flame was reported as a result of the reported damaged power cord.The biomed tech stated the power plug was replaced as a precaution and the machine was placed back in service without any further issue.The power cord was available to be returned for evaluation.The machine serial number was to be provided by the biomed tech.
 
Manufacturer Narrative
Plant investigation: the device and 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-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 user facility biomedical engineer (biomed tech) reported a discolored power cord plug and confirmed there was no patient involvement and no injury occurred.The biomed tech stated he was requested to perform an inspection on the machine and noted the power cord appeared discolored and burnt at the plug.The biomed tech stated the discovered power cord was replaced and confirmed no smoke or visible flames were reported from the power plug.The biomed tech the machine functioned as intended prior to the observation.No damage to the machine or receptacle was noted, and no burning smell, smoke or visible flame was reported as a result of the reported damaged power cord.The biomed tech stated the power plug was replaced as a precaution and the machine was placed back in service without any further issue.The power cord was available to be returned for evaluation.The machine serial number was to be provided by the biomed tech.
 
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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 Key7150434
MDR Text Key96021322
Report Number2937457-2017-01440
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861100859
UDI-Public00840861100859
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 Health Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 01/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number190610
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received01/22/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/30/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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