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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM WITHOUT CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM WITHOUT CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 190858
Device Problem Melted (1385)
Patient Problem No Patient Involvement (2645)
Event Date 03/12/2020
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 fresenius field service technician (fst) reported finding heat damage on the power plug of a 2008t machine. The damage was found while the fst was performing a semi-annual preventive maintenance (pm) check. The fst reported there was blackening around one of the prongs and stated that the plastic plug exhibited signs of melting. There was no burning smell, smoke, or arcing noted. In addition, there were no reports of sparks or flames. No damage was identified on any other components. The machine had approximately 9,860 hours on it. When in use, the machine is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet. There was no previous history of the machine failing the electrical leakage test. The fst replaced the power cord to resolve the reported issue. After the repair was completed, the machine underwent and passed functional testing. The machine has reportedly been returned to service. The damaged part was discarded and was therefore not available to be sent back for physical evaluation. There was no patient involvement associated with the reported event.
 
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Brand Name2008T HEMODIALYSIS SYSTEM WITHOUT 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 Key9909996
MDR Text Key194306233
Report Number2937457-2020-00571
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113427
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,Followup
Report Date 04/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number190858
Device Catalogue Number190858
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 Received04/14/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/27/2014
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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