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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 190713
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/20/2021
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 user facility biomedical technician (bmt) reported that a fresenius 2008t machine touch pad and keyboard were unresponsive.The bmt found a scorch mark on the motherboard and the c2 capacitor was blown.Additional information was requested, however to date has not been provided.
 
Event Description
A user facility biomedical technician (bmt) reported that a fresenius 2008t machine touch pad and keyboard were unresponsive.The bmt found a scorch mark on the motherboard and the c2 capacitor was blown.Additional information was requested, however to date has not been provided.
 
Manufacturer Narrative
Plant investigation: 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 user facility biomedical technician (bmt) reported that a fresenius 2008t machine touch pad and keyboard were unresponsive.The bmt found a scorch mark on the motherboard and the c2 capacitor was blown.Additional information was requested, however to date has not been provided.
 
Manufacturer Narrative
Plant investigation: the part was returned to the manufacturer for physical evaluation.Inspection of the received motherboard found capacitor c2 to be blown and a scorch mark on the board in the area of the damaged capacitor.Capacitor c2 was replaced.A test machine powered-up without alarm or failure with the received motherboard installed.A test machine powered-up without alarm or failure with the received motherboard installed.The test machine completed a self-test program without alarm or failure with the received motherboard installed.The keyboard and keypad passed diagnostic tests with the received motherboard installed.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.
 
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Brand Name
2008T HEMODIALYSIS SYS., WITH CDX
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
jason busch
920 winter st
waltham, MA 02451
9043166958
MDR Report Key13119678
MDR Text Key283077280
Report Number2937457-2021-02531
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861100897
UDI-Public00840861100897
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093902
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 02/23/2022
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 Number190713
Device Catalogue Number190713
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2022
Is the Reporter a Health Professional? Yes
Device AgeMO
Initial Date Manufacturer Received 12/20/2021
Initial Date FDA Received12/30/2021
Supplement Dates Manufacturer Received01/18/2022
02/21/2022
Supplement Dates FDA Received01/19/2022
02/23/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/14/2017
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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