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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
Catalog Number 191126
Device Problem Sparking (2595)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/20/2023
Event Type  malfunction  
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 sparks observed from a fresenius 2008t power cord.The biomedical technician (bmt) inspected the power cord, the power supply and brought machine into stable temperature/conductivity.Functional checks were performed and a heat disinfect was completed.The facility could not duplicate the sparks from the power cord.The technician was recommended to have in-house electricians to inspect the electrical outlet where machine was plugged in.There was no patient involvement or injury.Upon follow up, the bmt stated sparks had been noted from the power cord at the electrical outlet when the machine was turned on for setup.There was no smoke, burning smell or burnt component observed.The bmt confirmed that there was no harm because of this malfunction.There was no patient involvement and no adverse events, injuries, or medical intervention was noted as a result of the reported event.The bmt indicated the sparks had not previously occurred.The bmt stated that the machine and power outlet were both evaluated and tested and the issue was unable to be replicated, and it was unknown what may have caused the reported sparks.The bmt stated the machine has remained in service without further issue.
 
Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.Complaint investigation found objective evidence indicating a product problem, thus the complaint is confirmed.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 able to be confirmed.
 
Event Description
A user facility reported sparks observed from a fresenius 2008t power cord.The biomedical technician (bmt) inspected the power cord, the power supply and brought machine into stable temperature/conductivity.Functional checks were performed and a heat disinfect was completed.The facility could not duplicate the sparks from the power cord.The technician was recommended to have in-house electricians to inspect the electrical outlet where machine was plugged in.There was no patient involvement or injury.Upon follow up, the bmt stated sparks had been noted from the power cord at the electrical outlet when the machine was turned on for setup.There was no smoke, burning smell or burnt component observed.The bmt confirmed that there was no harm because of this malfunction.There was no patient involvement and no adverse events, injuries, or medical intervention was noted as a result of the reported event.The bmt indicated the sparks had not previously occurred.The bmt stated that the machine and power outlet were both evaluated and tested and the issue was unable to be replicated, and it was unknown what may have caused the reported sparks.The bmt stated the machine has remained in service without further issue.
 
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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
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 Key18194158
MDR Text Key328981596
Report Number0002937457-2023-01766
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861102099
UDI-Public00840861102099
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 12/13/2023
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 Number191126
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Initial Date Manufacturer Received 11/20/2023
Initial Date FDA Received11/22/2023
Supplement Dates Manufacturer Received12/13/2023
Supplement Dates FDA Received12/13/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/18/2021
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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