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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
The power supply cable was returned with heat damage to the power plug.Plastic was discolored around the terminal of the white wire in the power plug.The terminal had pitting.The power supply cable was measured to have good continuity and a test machine completed a self-test program without failure with the cable installed.The pitting on the power plug terminal indicates arcing within the outlet used at the customer¿s facility.Hospital grade outlets are required with the use of the t machine.A review of the device manufacturing records was performed on the reported serial number.There were no non-conformances or any associated rework during the manufacturing process which could be associated with the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was able to confirm the failure mode.A visual examination of the power cord revealed the presence of burn damage to the plug.Therefore, the complaint has been deemed confirmed.
 
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 Key7148904
MDR Text Key96125459
Report Number2937457-2017-01434
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 01/09/2018
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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