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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
Model Number 190713
Device Problems Thermal Decomposition of Device (1071); Melted (1385)
Patient Problem No Patient Involvement (2645)
Event Date 01/27/2020
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A user facility biomedical technician (biomed) reported that a 2008t machine would not power on. A fresenius field service technician (fst) was called onsite to repair the machine. While inspecting the machine, the fst discovered damage located on the right side of the distribution board on the ¿green box¿ or ¿junction block¿. The fst identified burnt wires entering the junction block, as well as evidence of melting on the junction block itself. The fst thinks that the machine would not turn on because the fuses in the power supply burned out, which limited the damage. The biomed did not report any burning smell, smoke, sparks, or flames. No other damaged components were found by the fst. There were no past reported issues with the machine failing the electrical leakage test. Approximately 4,512 hours were logged on the machine at the time of the event. The fst stated the machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet upon arrival at the facility, however, the machine had been pulled from service and relocated at that point. To resolve the reported issue, the fst replaced the entire power supply, the heater rod, and the distribution board. The machine passed functional testing and was returned to service; there have been no further issues. There was no patient involvement associated with the reported event. The parts that were replaced are reportedly available to be returned for evaluation.
 
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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
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 Key9733107
MDR Text Key180166353
Report Number2937457-2020-00350
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 company representative,user f
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 03/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/20/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model Number190713
Device Catalogue Number190713
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 Received03/04/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2019
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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