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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HD SYS. CDX BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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CONCORD MANUFACTURING 2008T HD SYS. CDX BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 191124
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/20/2024
Event Type  malfunction  
Event Description
A biomedical technician (biomed) at a user facility reported that a fresenius 2008t hemodialysis (hd) machine had a burn mark (discoloration) inside the power plug.The burned power plug was noticed during regular inspection.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 plug was the original fresenius part on the machine.The biomed reported that there was no melting, burning smell, smoke, spark, flame, or arcing observed.The biomed reported that the machine has not had any past problems with failing the electrical leakage test and that there was no damage observed on any other components.The machine hours was unknown.The machine is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The biomed replaced the plug, which resolved the issue.The biomed reported that the machine has been returned to service without issue.The power plug was reported to be available to be returned to the manufacturer for physical evaluation.
 
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
 
Manufacturer Narrative
Additional information: b5, d9, h3 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).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 biomedical technician (biomed) at a user facility reported that a fresenius 2008t hemodialysis (hd) machine had a burn mark (discoloration) inside the power plug.The burned power plug was noticed during regular inspection.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 plug was the original fresenius part on the machine.The biomed reported that there was no melting, burning smell, smoke, spark, flame, or arcing observed.The biomed reported that the machine has not had any past problems with failing the electrical leakage test and that there was no damage observed on any other components.The machine hours was unknown.The machine is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The biomed replaced the plug, which resolved the issue.The biomed reported that the machine has been returned to service without issue.The power plug was not returned to the manufacturer for physical evaluation.
 
Manufacturer Narrative
Plant investigation: the power supply cable assembly was returned to the manufacturer for physical evaluation.The power supply cable assembly was returned with signs of thermal damage on the neutral side (white wire) of the power plug.Further inspection found pitting on the prong of the neutral side of the plug.The returned sample was then subjected to a functional checks.A continuity check on the neutral, hot, and ground wires from end to end was satisfactory.The power supply cable assembly was installed onto the power supply of a test machine to test for any failures.There were no failures during the initial power up.A self-test was completed without failures.There was no additional damage or thermal event that occurred on the power supply cable assembly during testing.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 biomedical technician (biomed) at a user facility reported that a fresenius 2008t hemodialysis (hd) machine had a burn mark (discoloration) inside the power plug.The burned power plug was noticed during regular inspection.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 plug was the original fresenius part on the machine.The biomed reported that there was no melting, burning smell, smoke, spark, flame, or arcing observed.The biomed reported that the machine has not had any past problems with failing the electrical leakage test and that there was no damage observed on any other components.The machine hours was unknown.The machine is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The biomed replaced the plug, which resolved the issue.The biomed reported that the machine has been returned to service without issue.The power plug was reported to be available to be returned to the manufacturer for physical evaluation.
 
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Brand Name
2008T HD SYS. CDX BLUE STAR
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 Key18960533
MDR Text Key338375724
Report Number0002937457-2024-00489
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861102082
UDI-Public00840861102082
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173972
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
Report Date 04/18/2024
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 Number191124
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Device AgeMO
Initial Date Manufacturer Received 03/20/2024
Initial Date FDA Received03/22/2024
Supplement Dates Manufacturer Received04/12/2024
04/17/2024
Supplement Dates FDA Received04/15/2024
04/18/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/24/2020
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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