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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HD SYS. W/O CDX W/BIBAG BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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CONCORD MANUFACTURING 2008T HD SYS. W/O CDX W/BIBAG BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 191130
Device Problems Thermal Decomposition of Device (1071); Smoking (1585)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/16/2024
Event Type  malfunction  
Event Description
A user facility reported a fresenius 2008t hemodialysis (hd) machine had thermal decomposition of the power supply.A field service technician (fst) replaced the power supply.Upon follow-up, the biomedical technician (bmt) stated a burning smell was noted and the machine began smoking when the machine was turned on and was immediately turned off.Per bmt the power control board within the power supply appeared burnt.The bmt confirmed the smoke detectors were not triggered.The bmt reported there was no spark or flame observed.The power supply was noticed during annual inspection preventative maintenance.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.Per bmt the power supply was replaced by the fst and the issue was resolved.The bmt reported the unit was returned to service at the user facility without reoccurrence of the event.The machine has not had any past problems with failing the electrical leakage test and there was no damage observed on any other components.The machine has approximately 889 hours and is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The bmt reported that the power supply component was available to be returned to the manufacturer for physical evaluation.
 
Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A user facility reported a fresenius 2008t hemodialysis (hd) machine had thermal decomposition of the power supply.A field service technician (fst) replaced the power supply.Upon follow-up, the biomedical technician (bmt) stated a burning smell was noted and the machine began smoking when the machine was turned on and was immediately turned off.Per bmt the power control board within the power supply appeared burnt.The bmt confirmed the smoke detectors were not triggered.The bmt reported there was no spark or flame observed.The power supply was noticed during annual inspection preventative maintenance.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.Per bmt the power supply was replaced by the fst and the issue was resolved.The bmt reported the unit was returned to service at the user facility without reoccurrence of the event.The machine has not had any past problems with failing the electrical leakage test and there was no damage observed on any other components.The machine has approximately 889 hours and is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The bmt reported that the power supply component was available to be returned to the manufacturer for physical evaluation.
 
Manufacturer Narrative
Additional information: d9, h3 plant investigation: the actual device was returned to the manufacturer for physical evaluation.A visual inspection of the returned power supply found thermal damage to varistor (rv1) and soot on the back of the power control board.There is no other damage found on the power control board, and power supply.Install the power supply (as-received condition) onto a test machine for testing.No problems during the initial power up.Dialysis mode functioned properly without any failures.A self-test program completed without any failures.Varistor (rv1) was replaced on the power control board for retesting.No problems during power up.Dialysis mode functioned properly without any failures.A self-test program completed without any failures.The varistor or metal oxide varistor (mov) is a special resistor that is used to protect circuits against high transient (short term) voltage.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 event is confirmed due to component failure.
 
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Brand Name
2008T HD SYS. W/O CDX W/BIBAG 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 Key18936872
MDR Text Key338066391
Report Number0002937457-2024-00471
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861102112
UDI-Public00840861102112
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
Report Date 04/11/2024
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 Number191130
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Device AgeMO
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/19/2024
Supplement Dates Manufacturer Received04/11/2024
Supplement Dates FDA Received04/11/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/06/2023
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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