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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HD SYS. CDX W/BIBAG BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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CONCORD MANUFACTURING 2008T HD SYS. CDX W/BIBAG BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 191126
Device Problems Thermal Decomposition of Device (1071); Smoking (1585)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/26/2021
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.¿.
 
Event Description
A facility biomedical technician (biomed tech) reported to fresenius technical support that the power supply on a 2008t machine was smoking.Upon follow up, the biomed tech confirmed the reported product complaint.The biomed tech stated they smelled burning and saw smoke coming from the power supply during troubleshooting.Additionally, the biomed tech stated while troubleshooting the 2008t machine, two boards in the bibag module were also found burned.The cause of the damage was unknown.The approximate hours on the machine were unknown.The biomed tech stated the power supply and the two bibag boards were replaced which resolved the machine issue.The machine was reported to have been returned to service and is operating without any additional issues.The biomed tech confirmed the samples are available for return to the manufacturer for physical evaluation.The biomed tech confirmed there was no patient involved with the reported event.No harm or adverse events was experienced due to the malfunction.
 
Manufacturer Narrative
Plant investigation: although it was stated that the complaint samples were available to be returned, to date no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was 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.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
 
Event Description
A facility biomedical technician (biomed tech) reported to fresenius technical support that the power supply on a 2008t machine was smoking.Upon follow up, the biomed tech confirmed the reported product complaint.The biomed tech stated they smelled burning and saw smoke coming from the power supply during troubleshooting.Additionally, the biomed tech stated while troubleshooting the 2008t machine, two boards in the bibag module were also found burned.The cause of the damage was unknown.The approximate hours on the machine were unknown.The biomed tech stated the power supply and the two bibag boards were replaced which resolved the machine issue.The machine was reported to have been returned to service and is operating without any additional issues.The biomed tech confirmed the samples are available for return to the manufacturer for physical evaluation.The biomed tech confirmed there was no patient involved with the reported event.No harm or adverse events was experienced due to the malfunction.
 
Event Description
A facility biomedical technician (biomed tech) reported to fresenius technical support that the power supply on a 2008t machine was smoking.Upon follow up, the biomed tech confirmed the reported product complaint.The biomed tech stated they smelled burning and saw smoke coming from the power supply during troubleshooting.Additionally, the biomed tech stated while troubleshooting the 2008t machine, two boards in the bibag module were also found burned.The cause of the damage was unknown.The approximate hours on the machine were unknown.The biomed tech stated the power supply and the two bibag boards were replaced which resolved the machine issue.The machine was reported to have been returned to service and is operating without any additional issues.The biomed tech confirmed the samples are available for return to the manufacturer for physical evaluation.The biomed tech confirmed there was no patient involved with the reported event.No harm or adverse events was experienced due to the malfunction.
 
Manufacturer Narrative
Additional information: d9, h3 plant investigation: the power supply was returned to the manufacturer for physical evaluation with signs heat damage on the transformer.No other components on the returned sample was damaged.There was no damage on the power control board and power plug.The power supply (as-received condition) was installed onto a test machine to test for the reported failure.The test machine powered on without failures.During dialysis, a burning smell was observed, and smoke occurred from the transformer of the power supply.Testing was halted and the power supply was removed for troubleshooting.The transformer was replaced on the power supply and the power supply was installed back onto the test machine for testing.The test machine powered on without failures and dialysis functioned properly.The self-test program completed without any failures.There was no burning smell observed and no smoke occurred during testing.The failure was due to a faulty transformer.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 investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
 
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Brand Name
2008T HD SYS. 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
MDR Report Key11803194
MDR Text Key249913206
Report Number2937457-2021-01013
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861102099
UDI-Public00840861102099
Combination Product (y/n)N
PMA/PMN Number
K173972
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup,Followup
Report Date 07/12/2021
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 Model Number191126
Device Catalogue Number191126
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/24/2021
Device AgeMO
Initial Date Manufacturer Received 04/26/2021
Initial Date FDA Received05/10/2021
Supplement Dates Manufacturer Received05/12/2021
07/02/2021
Supplement Dates FDA Received05/20/2021
07/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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