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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 Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/27/2022
Event Type  malfunction  
Event Description
A user facility biomedical technician (biomed) reported that a 2008t hemodialysis (hd) machine had a burn mark on the distribution board.Prior to discovering this, the machine was giving a message indicating the temperature was exceeding 95 degrees celsius following a heat disinfect cycle.In addition to the burn mark on the distribution board, the biomed found corrosion on the heater rod.No damage was identified on any other components.The biomed replaced the heater rod and the distribution board to resolve the issue.It was confirmed that the distribution board was an original fresenius part.The biomed confirmed there was no burning smell or smoke.Additionally, there were no signs of any sparks, or flames.The machine had approximately 45,000 hours on it.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet and had no previous history of failing the electrical leakage test.The biomed confirmed the machine was returned to service.The damaged distribution board was not available to be returned for evaluation because the biomed discarded it.There were also no photos available.The biomed confirmed there was no patient involvement associated with the event.
 
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).However, the manufacturer was able to determine a causal relationship between the objective evidence provided by the customer and the reported event.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 event has been confirmed.
 
Event Description
A user facility biomedical technician (biomed) reported that a 2008t hemodialysis (hd) machine had a burn mark on the distribution board.Prior to discovering this, the machine was giving a message indicating the temperature was exceeding 95 degrees celsius following a heat disinfect cycle.In addition to the burn mark on the distribution board, the biomed found corrosion on the heater rod.No damage was identified on any other components.The biomed replaced the heater rod and the distribution board to resolve the issue.It was confirmed that the distribution board was an original fresenius part.The biomed confirmed there was no burning smell or smoke.Additionally, there were no signs of any sparks, or flames.The machine had approximately 45,000 hours on it.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet and had no previous history of failing the electrical leakage test.The biomed confirmed the machine was returned to service.The damaged distribution board was not available to be returned for evaluation because the biomed discarded it.There were also no photos available.The biomed confirmed there was no patient involvement associated with the event.
 
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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 Key16127268
MDR Text Key306971542
Report Number0002937457-2023-00035
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 02/02/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2023
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? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received01/13/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/31/2013
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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