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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); Loss of Power (1475)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/18/2022
Event Type  malfunction  
Manufacturer Narrative
Plant investigation: power supply was returned disassembled (loose components).Encountered a broken triac assembly and broken ground wire on power cord (physical damage).Encountered a missing rocker switch and a missing ground wire from c1 capacitor to ground post (missing components) and heat damage on the transformer wires (physical damage).Reassembled power supply with ¿known-good¿ rocker switch, power cord, triac assembly, and installed ground wire from c1 capacitor to ground post.The transformer was not replaced.Install power supply to test machine for testing.Power on test failed.Failure was due to the damaged wire from the transformer.Replace transformer with a ¿known-good¿ transformer on power supply.Reinstall onto test machine for testing.Power on test passed.Rinse program completed without failures.Dialysis functioned properly.Self-test passed.A product history review was completed during the investigation.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.Upon completion of the evaluation, the reported issue was confirmed and the cause was determined to be due to the thermal damage on the transformer.The component was returned to return goods following the evaluation.
 
Event Description
A biomedical technician (bmt) contacted technical support and informed a technical support technician (tst) a 2008t machine alarms e.08 on the blood pump and a bp no comm error on the display upon power up.There was no patient involvement or adverse event reported.Multiple attempts have been made to gather additional information, but fresenius has not received any further details.Upon physical evaluation of the power supply by the manufacturer, it was identified that there was heat damage noted on the transformer wires.
 
Event Description
A biomedical technician (bmt) contacted technical support and informed a technical support technician (tst) a 2008t machine alarms e.08 on the blood pump and a bp no comm error on the display upon power up.There was no patient involvement or adverse event reported.Multiple attempts have been made to gather additional information, but fresenius has not received any further details.Upon physical evaluation of the power supply by the manufacturer, it was identified that there was heat damage noted on the transformer wires.
 
Manufacturer Narrative
Additional information: h6 investigation findings.
 
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Brand Name
2008T HEMODIALYSIS SYS., WITH CDX
Type of Device
DIALYZER, 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
jessica trujillo
920 winter st
waltham, MA 02451
6174175172
MDR Report Key14955689
MDR Text Key295480242
Report Number0002937457-2022-01138
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861100897
UDI-Public00840861100897
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,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 07/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number190713
Device Catalogue Number190713
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/05/2022
Is the Reporter a Health Professional? Yes
Device AgeMO
Initial Date Manufacturer Received 07/07/2022
Initial Date FDA Received07/08/2022
Supplement Dates Manufacturer Received07/11/2022
Supplement Dates FDA Received07/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/12/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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