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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 Problem Thermal Decomposition of Device (1071)
Patient Problem No Patient Involvement (2645)
Event Date 11/12/2020
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 biomedical technician (biomed) at a user facility reported finding burn damage to wire connections on valve 30 of a fresenius 2008t hemodialysis (hd) machine. The wire connections appeared to be black. The burn damage was found during troubleshooting after the machine alarmed with a flow error during testing. A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction. The machine has approximately 40,000 hours. The biomed reported that there was no damage observed on any other components, or any other additional issues, associated with valve 30. The biomed replaced valve 30, which resolved the issue. The unit was returned to service at the user facility without issue and without reoccurrence of the event. The complaint sample was discarded by the biomed and is not available to be returned to the manufacturer for physical 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 Key10928038
MDR Text Key218952414
Report Number2937457-2020-02149
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,Followup
Report Date 12/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number190713
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 Received12/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/08/2012
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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