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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 Melted (1385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/16/2021
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 was failing tmp tests. Biomed is still troubleshooting the reported issue and stated the machine is still out of service. The check valve, the dialysate pressure transducer #9, along with a few other parts have been replaced and the venous pressure was calibrated but none of those resolved the reported issue. The tech explained they saw, on top of the balancing chamber, that a valve (possibly a solenoid valve) had melted. Upon follow up, biomed did not observe any burning smell, smoke, spark, flame, arcing, or any other visible heat or electrical damage related to the melting found on the valve. Biomed stated that the machine has approximately 13,000 hours and that the valve is the original fresenius part on the machine. Biomed stated that the entire balance chamber was replaced, however the machine is still failing tmp tests for hi and low, and that the machine is not back in service. Additionally, biomed confirmed that there was no damage observed on any other components. Biomed confirmed that the machine has had not problems with passing electrical leakage tests and is plugged into a hospital grade ground fault circuit interrupter (gfci) outlet. Biomed confirmed that 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. Biomed confirmed that the balance chamber and valve were discarded and are not available for return 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 Key12350614
MDR Text Key267561725
Report Number2937457-2021-01750
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 user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup,Followup
Report Date 09/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/20/2021
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 Received09/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/31/2015
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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