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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 Thermal Decomposition of Device (1071)
Patient Problem No Patient Involvement (2645)
Event Date 12/11/2017
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 burnt power cord.There was no patient involvement or harm reported.Additional follow-up was made with the clinic manager, who confirmed there was no patient involvement and no injury occurred.The clinic manager confirmed no burning smell, smoke or visible flames were reported from the power plug, and the machine functioned as intended.The power plug was replaced as a precaution and the machine was placed back in service without any further issue.The power cord was returned by the biomed tech for evaluation.
 
Manufacturer Narrative
Plant investigation: the power cord was returned with heat damage on the neutral side of the plug.Signs of pitting was found on both sides of the damaged prong (neutral) of the plug.There are no heat damage on the hot and ground side of the plug and no heat damage on the cord.Measurements were taking on each wires of the power cord which have continuity and the resistance between the wires are open as expected.The power cord was installed onto a test machine and plugged into an outlet which was tight and cannot be easily unplugged.The test machine powered on and a self-test was completed without failures.There were no additional damage on the plug during testing.The reported physical damage on the power cord is confirmed.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 burnt power cord.There was no patient involvement or harm reported.Additional follow-up was made with the clinic manager, who confirmed there was no patient involvement and no injury occurred.The clinic manager confirmed no burning smell, smoke or visible flames were reported from the power plug, and the machine functioned as intended.The power plug was replaced as a precaution and the machine was placed back in service without any further issue.The power cord was returned by the biomed tech for evaluation.
 
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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 Key7148788
MDR Text Key95928553
Report Number2937457-2017-01431
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861100897
UDI-Public00840861100897
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 Health Professional
Type of Report Initial,Followup
Report Date 01/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number190713
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/27/2017
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received01/02/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/17/2015
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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