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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 Problem Arcing (2583)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/28/2024
Event Type  malfunction  
Event Description
A user facility biomedical technician (biomed) reported to fresenius that thermal decomposition was identified within the 2008t machine.The biomed confirmed the reported product complaint during follow-up and provided additional information.The biomed stated that a 2008t machine was experiencing high temperatures during testing and heat disinfection.The biomed stated that upon troubleshooting the machine issue, arcing was observed on the power supply from the power switch.The biomed stated upon opening the machine a burning smell was also noted.The biomed stated that he did not observe any smoke, spark, flame, or any other visible heat or electrical damage related to the burnt power supply.The biomed stated that the machine has approximately 18,393 hours and that the power supply is the original fresenius part on the machine.The biomed stated that the power supply and power logic board were replaced, which resolved the machine issues.The machine has passed functional testing and will be returned to service.Additionally, the biomed confirmed that there was no damage observed on any other components, or any other additional issues.The 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.The biomed confirmed that the samples were discarded and that it is not available for return to the manufacturer for physical evaluation.Additionally no photographs of the reported issue are available to be obtained for review.
 
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
 
Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation and an on-site evaluation was not performed by a fresenius field service technician (fst).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.Objective evidence was provided to the manufacturer during the investigation which indicated a product problem, thus the complaint is confirmed.
 
Event Description
A user facility biomedical technician (biomed) reported to fresenius that thermal decomposition was identified within the 2008t machine.The biomed confirmed the reported product complaint during follow-up and provided additional information.The biomed stated that a 2008t machine was experiencing high temperatures during testing and heat disinfection.The biomed stated that upon troubleshooting the machine issue, arcing was observed on the power supply from the power switch.The biomed stated upon opening the machine a burning smell was also noted.The biomed stated that he did not observe any smoke, spark, flame, or any other visible heat or electrical damage related to the burnt power supply.The biomed stated that the machine has approximately 18,393 hours and that the power supply is the original fresenius part on the machine.The biomed stated that the power supply and power logic board were replaced, which resolved the machine issues.The machine has passed functional testing and will be returned to service.Additionally, the biomed confirmed that there was no damage observed on any other components, or any other additional issues.The 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.The biomed confirmed that the samples were discarded and that it is not available for return to the manufacturer for physical evaluation.Additionally no photographs of the reported issue are available to be obtained for review.
 
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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 Key19020008
MDR Text Key339296323
Report Number0002937457-2024-00546
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,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 05/06/2024
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 Health Professional
Device Catalogue Number190713
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Initial Date Manufacturer Received 04/01/2024
Initial Date FDA Received04/02/2024
Supplement Dates Manufacturer Received05/03/2024
Supplement Dates FDA Received05/06/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/17/2014
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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