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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 Problems Thermal Decomposition of Device (1071); Sparking (2595)
Patient Problem No Patient Involvement (2645)
Event Date 08/22/2017
Event Type  malfunction  
Manufacturer Narrative
Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed. An investigation of the device manufacturing records was conducted and verified that there were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event. In addition, a device history records (dhr) review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements. As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and the complaint could not be confirmed. Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A biomedical technician (biomed) at the user facility reported that a 2008t hemodialysis (hd) machine had low flow error message in rinse mode. No patient was connected to the machine at the time of the incident. Therefore, no patient was involved. The biomed was unable to duplicate the flow errors. Subsequently, the machine powered down with audible alarm in dialysis mode. A burning smell was coming from the power supply. The biomed performed a visual assessment and found the rocker switch showing signs of heat. The biomed replaced the rocker switch to resolve the issue. The biomed observed a spark from the power supply. The bridge rectifier in the power supply had burn damage. The bridge rectifier was replaced to resolve the issue. The machine now gives a low temperature message in dialysis mode. Attempts to gather additional event related information have been unsuccessful. Therefore, the current repair status of the machine is unknown and it is not known if the unit has been returned to service at the user facility. The power rocker switch and the bridge rectifier are not available to be returned to the manufacturer for evaluation as they have been discarded by the user facility.
 
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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 Key6862756
MDR Text Key250425632
Report Number2937457-2017-00883
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 consumer,user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 10/23/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Biomedical Engineer
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 Received09/26/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/26/2013
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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