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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HD SYS. CDX BLUE STAR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008T HD SYS. CDX BLUE STAR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 191124
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Patient Involvement (2645)
Event Date 01/06/2021
Event Type  malfunction  
Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation. However, an on-site evaluation was performed by a fresenius field service technician (fst). To resolve the reported issue, the fst replaced the power plug. A records review was performed on the reported serial number. An investigation of the device manufacturing records was conducted by the manufacturer. There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to 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 reported failure mode. During the machine inspection, the fresenius fst identified a burn mark on one of the power plugs prongs. Therefore, the complaint event was confirmed.
 
Event Description
A hemodialysis (hd) user facility requested onsite service from a fresenius field service technician (fst) to evaluate a 2008t hd machine that had a burned out power plug. Upon follow-up with the fst, it was confirmed that a burn mark was identified on one of the power plug's prongs. To resolve the reported issue, the fst replaced the power plug. There was no burning smell, smoke, melting, or arcing noted, and there were no reports of sparks or flames. No damage was identified on any other components. The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet, and there was no previous history of the machine failing the electrical leakage test. There were 4,701 hours on the machine at the time of the repair. After the repair was completed, the machine was returned to service. The damaged power plug was not available to be returned for evaluation as it was reportedly discarded. In addition, photos of the component were not available. There was no patient involvement associated with the reported event.
 
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Brand Name2008T HD SYS. CDX BLUE STAR
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer (Section G)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer Contact
matthew amaral
920 winter st
waltham, MA 02451
7816999758
MDR Report Key11233793
MDR Text Key228782884
Report Number2937457-2021-00143
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173972
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 01/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number191124
Device Catalogue Number191124
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received01/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/19/2019
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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