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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 190766
Device Problem Melted (1385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/14/2022
Event Type  malfunction  
Event Description
A user facility biomedical technician (bmt) reported that a fresenius 2008t machine experienced a blank display and smelled smoke.Upon follow up, the bmt confirmed the reported event, stating the machine was pulled from the treatment floor due to a blank display.Additionally, the bmt initially thought the burning (or smoke) smell was coming from the card cage.However, after opening up the card cage they noticed a ¿buildup of molten plastic¿ underneath valve 105 (v105).The bmt confirmed the component had melted.After finding the damaged component, the bmt subsequently replaced it with a new part.The damaged valve was discarded and no photos of the component were available.No other parts exhibited any type of thermal damage.The bmt confirmed they were still troubleshooting the blank screen issue.No additional details are available at this time.The cause of the event is unknown.The bmt stated that the machine hours were unknown.The bmt confirmed that the machine has not had any past problems with failing the electrical leakage test prior to the event.The bmt confirmed that the machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The bmt confirmed that no patient was connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction.
 
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
 
Event Description
A user facility biomedical technician (bmt) reported that a fresenius 2008t machine experienced a blank display and smelled smoke.Upon follow up, the bmt confirmed the reported event, stating the machine was pulled from the treatment floor due to a blank display.Additionally, the bmt initially thought the burning (or smoke) smell was coming from the card cage.However, after opening up the card cage they noticed a ¿buildup of molten plastic¿ underneath valve 105 (v105).The bmt confirmed the component had melted.After finding the damaged component, the bmt subsequently replaced it with a new part.The damaged valve was discarded and no photos of the component were available.No other parts exhibited any type of thermal damage.The bmt confirmed they were still troubleshooting the blank screen issue.No additional details are available at this time.The cause of the event is unknown.The bmt stated that the machine hours were unknown.The bmt confirmed that the machine has not had any past problems with failing the electrical leakage test prior to the event.The bmt confirmed that the machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The bmt confirmed that no patient was connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction.
 
Manufacturer Narrative
Correction: h6 investigation findings.
 
Event Description
A user facility biomedical technician (bmt) reported that a fresenius 2008t machine experienced a blank display and smelled smoke.Upon follow up, the bmt confirmed the reported event, stating the machine was pulled from the treatment floor due to a blank display.Additionally, the bmt initially thought the burning (or smoke) smell was coming from the card cage.However, after opening up the card cage they noticed a ¿buildup of molten plastic¿ underneath valve 105 (v105).The bmt confirmed the component had melted.After finding the damaged component, the bmt subsequently replaced it with a new part.The damaged valve was discarded and no photos of the component were available.No other parts exhibited any type of thermal damage.The bmt confirmed they were still troubleshooting the blank screen issue.No additional details are available at this time.The cause of the event is unknown.The bmt stated that the machine hours were unknown.The bmt confirmed that the machine has not had any past problems with failing the electrical leakage test prior to the event.The bmt confirmed that the machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The bmt confirmed that no patient was connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction.
 
Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.However, an on-site evaluation was performed by a fresenius biomedical technician (bmt).To resolve the reported burn damage issue, the bmt replaced the valve 105.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 confirm the reported failure mode.During the machine inspection, the fresenius bmt identified a ¿buildup of molten plastic¿ underneath valve 105 (v105).Therefore, the complaint event was confirmed.
 
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Brand Name
2008T HEMODIALYSIS SYSTEM W/BIBAG
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 Key15001783
MDR Text Key302943981
Report Number0002937457-2022-01171
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861100910
UDI-Public00840861100910
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,Followup
Report Date 08/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number190766
Device Catalogue Number190766
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received08/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/02/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
FRESENIUS 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES
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