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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 Thermal Decomposition of Device (1071)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/06/2022
Event Type  malfunction  
Event Description
A biomedical technician (biomed) at a user facility reported that a fresenius 2008t hemodialysis (hd) machine had a burned and melted distribution board and a burned heater rod.The distribution board was burned and melted where it connects to the heater rod.The burned board and heater rod were noticed during machine repair after the machine was pulled from service for issues with temperature.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 13,000 hours and the biomed explained that the parts were previously replaced once approximately 7 months/2,000 machine hours ago and are not the original fresenius parts 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 distribution board and heater rod.The biomed replaced the distribution board and the heater rod, as well as the power supply as a precaution, which resolved the issue.The unit was returned to service at the user facility without issue and without reoccurrence of the event.The complaint samples were discarded by the biomed and are not available to be returned to the manufacturer for physical evaluation.
 
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
 
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).However a photograph of the sample was provided.The manufacturer was able to determine a causal relationship between the objective evidence and the reported event.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 confirmed the reported issue.
 
Event Description
A biomedical technician (biomed) at a user facility reported that a fresenius 2008t hemodialysis (hd) machine had a burned and melted distribution board and a burned heater rod.The distribution board was burned and melted where it connects to the heater rod.The burned board and heater rod were noticed during machine repair after the machine was pulled from service for issues with temperature.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 13,000 hours and the biomed explained that the parts were previously replaced once approximately 7 months/2,000 machine hours ago and are not the original fresenius parts 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 distribution board and heater rod.The biomed replaced the distribution board and the heater rod, as well as the power supply as a precaution, which resolved the issue.The unit was returned to service at the user facility without issue and without reoccurrence of the event.The complaint samples were discarded by the biomed and are not available to be returned to the manufacturer for physical evaluation.
 
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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 Key14743474
MDR Text Key294372880
Report Number0002937457-2022-00994
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 07/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2022
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 Received07/06/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/20/2018
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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