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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
Catalog Number 190713
Device Problems Thermal Decomposition of Device (1071); Melted (1385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/20/2023
Event Type  malfunction  
Event Description
A user facility biomedical technician (biomed) contacted fresenius technical support (ts) for assistance troubleshooting a low flow error message that was occurring on a fresenius 2008t hemodialysis (hd) machine.There was no patient involvement associated with the reported event.The biomed said there were no audible alarms because the dialysate lines were on the shunt.The biomed also confirmed there were no valve errors or filling programs.The diasafe plus filter was replaced the previous month.The biomed tried calibrating the deaeration, loading, and flow pressures.They also tried changing the chamber full switch (cfs), the flow motor, and the pump head.The ts representative advised the biomed to do a manual balancing chamber valve/diaphragm leak test or to swap the sensor, actuator, or function boards.Upon follow-up, the biomed stated that they were able to resolve the reported issue by replacing a burnt/melted valve.The damaged valve was one of the valves on top of the balancing chamber ¿ the biomed wasn¿t sure what the valve number was.The valve was confirmed to be an original fresenius part that was installed on the machine.The biomed said the machine had approximately 30,000 hours on it (the exact number was unknown).It was confirmed the machine had no past problems with failing the electrical leakage test and it was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.No other parts were damaged.The biomed confirmed the damaged valve was available to be sent back for evaluation.
 
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) contacted fresenius technical support (ts) for assistance troubleshooting a low flow error message that was occurring on a fresenius 2008t hemodialysis (hd) machine.There was no patient involvement associated with the reported event.The biomed said there were no audible alarms because the dialysate lines were on the shunt.The biomed also confirmed there were no valve errors or filling programs.The diasafe plus filter was replaced the previous month.The biomed tried calibrating the deaeration, loading, and flow pressures.They also tried changing the chamber full switch (cfs), the flow motor, and the pump head.The ts representative advised the biomed to do a manual balancing chamber valve/diaphragm leak test or to swap the sensor, actuator, or function boards.Upon follow-up, the biomed stated that they were able to resolve the reported issue by replacing a burnt/melted valve.The damaged valve was one of the valves on top of the balancing chamber ¿ the biomed wasn¿t sure what the valve number was.The valve was confirmed to be an original fresenius part that was installed on the machine.The biomed said the machine had approximately 30,000 hours on it (the exact number was unknown).It was confirmed the machine had no past problems with failing the electrical leakage test and it was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.No other parts were damaged.The biomed confirmed the damaged valve was available to be sent back for evaluation.
 
Manufacturer Narrative
Additional information: h3 plant investigation: although a sample was reported to be available for manufacturer evaluation, to date no parts have been received.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).However, the complaint investigation found objective evidence indicating a product problem and thus the complaint was confirmed.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The reported complaint has been confirmed.
 
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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 Key18314269
MDR Text Key330309099
Report Number0002937457-2023-01870
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861100897
UDI-Public00840861100897
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150708
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
Report Date 01/15/2024
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 Catalogue Number190713
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Device AgeMO
Initial Date Manufacturer Received 11/23/2023
Initial Date FDA Received12/12/2023
Supplement Dates Manufacturer Received12/28/2023
Supplement Dates FDA Received01/15/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/14/2015
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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