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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
Catalog Number 190766
Device Problems Thermal Decomposition of Device (1071); Melted (1385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/02/2024
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 biomedical technician (biomed) at a user facility reported that a fresenius 2008t hemodialysis (hd) machine had a burned and melted valve 103.The valve was melting from a crack that had formed on it.The burned valve was noticed during machine repair.The machine was initially evaluated after experiencing a flow error and receiving the air detector alarm.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.The machine has approximately 25,000 hours and the valve was the original fresenius part on the machine.The biomed reported that there was no damage observed on any other components, or any other additional issues, associated with the burned and melted valve.The biomed replaced valve 103, which resolved the issue.Preventative maintenance was also performed where brushes were replaced and calibrations were verified.The unit was returned to service at the user facility without issue and without reoccurrence of the event.The valve is available to be returned to the manufacturer for physical evaluation.
 
Event Description
A biomedical technician (biomed) at a user facility reported that a fresenius 2008t hemodialysis (hd) machine had a burned and melted valve 103.The valve was melting from a crack that had formed on it.The burned valve was noticed during machine repair.The machine was initially evaluated after experiencing a flow error and receiving the air detector alarm.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.The machine has approximately 25,000 hours and the valve was the original fresenius part on the machine.The biomed reported that there was no damage observed on any other components, or any other additional issues, associated with the burned and melted valve.The biomed replaced valve 103, which resolved the issue.Preventative maintenance was also performed where brushes were replaced and calibrations were verified.The unit was returned to service at the user facility without issue and without reoccurrence of the event.The valve is available to be returned to the manufacturer for physical evaluation.
 
Manufacturer Narrative
Additional information: d9, h3 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).However the reported issue was confirmed based on the provided information.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.
 
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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 Key18676046
MDR Text Key335012973
Report Number0002937457-2024-00241
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
Report Date 03/05/2024
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 Health Professional
Device Catalogue Number190766
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Initial Date Manufacturer Received 02/02/2024
Initial Date FDA Received02/09/2024
Supplement Dates Manufacturer Received03/04/2024
Supplement Dates FDA Received03/05/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/25/2018
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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