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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 12/07/2021
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 biomedical technician (bmt) at a user facility reported a fresenius 2008t hemodialysis (hd) machine had a burnt ui - mics board when they tried to load chairside.The bmt reported there was no smoke, spark, or flame observed.The burned actuator board was noticed during dialysis mode of preventative maintenance and 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 21,000 hours and the ui - mics board was the original fresenius part on the machine.Per bmt a replacement ui - mics board was ordered and is pending receipt.The bmt reported the machine remains out of service.The bmt reported that the ui - mics board component was no longer available to be returned to the manufacturer for physical evaluation.
 
Manufacturer Narrative
Correction: b5.
 
Event Description
A biomedical technician (bmt) at a user facility reported a fresenius 2008t hemodialysis (hd) machine had a burnt ui - mics board when they tried to load chairside.The bmt reported there was no smoke, spark, or flame observed.The burned ui - mics board was noticed during dialysis mode of preventative maintenance and 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 21,000 hours and the ui - mics board was the original fresenius part on the machine.Per bmt a replacement ui - mics board was ordered and is pending receipt.The bmt reported the machine remains out of service.The bmt reported that the ui - mics board component was no longer available to be returned to the manufacturer for physical evaluation.
 
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 biomedical technician (bmt) at a user facility reported a fresenius 2008t hemodialysis (hd) machine had a burnt ui - mics board when they tried to load chairside.The bmt reported there was no smoke, spark, or flame observed.The burned ui - mics board was noticed during dialysis mode of preventative maintenance and 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 21,000 hours and the ui - mics board was the original fresenius part on the machine.Per bmt a replacement ui - mics board was ordered and is pending receipt.The bmt reported the machine remains out of service.The bmt reported that the ui - mics board component was no longer available to be returned to the manufacturer for physical evaluation.
 
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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 Key12969648
MDR Text Key281998808
Report Number2937457-2021-02419
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 Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 12/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2021
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? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received12/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/15/2015
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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