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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO BCT, LTD REVEOS AUTOMATED WHOLE BLOOD PROCESSING SYSTEM; REVEOS LR CPD/SAGM 450ML SYM W/ARM
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TERUMO BCT, LTD REVEOS AUTOMATED WHOLE BLOOD PROCESSING SYSTEM; REVEOS LR CPD/SAGM 450ML SYM W/ARM Back to Search Results
Catalog Number 54FG456S01
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/20/2023
Event Type  malfunction  
Manufacturer Narrative
Investigation: the run data file (rdf) was analyzed for this event root cause cannot be determined from the run data file (rdf).The blood and reveos system appears normal based on run data file (rdf) data.The contamination could be related to factors that occurred after processing and during rbc filtration.Investigation is in process, a follow-up report will be provided.
 
Event Description
The customer would like the run data file investigated to determine a possible cause for the elevated white blood cell (wbc) content in the platelet product.There was not a transfusion recipient or patient involved at the time of the residual wbc testing, therefore no patient information is reasonably known at the time of the event.Donor unit id: (b)(6) the collection set is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.
 
Event Description
The customer would like the run data file investigated to determine a possible cause for the elevated white blood cell (wbc) content in the red blood cell (rbc) product.There was not a transfusion recipient or patient involved at the time of the residual wbc testing, therefore no patient information is reasonably known at the time of the event.Donor unit id: (b)(6) the collection set is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.
 
Manufacturer Narrative
This report is being filed to provide additional information in h.6, h.10 and h.11.Corrected information is provided in d.3.Investigation: the run data file (rdf) was analyzed for this event.Root cause cannot be determined from the run data file (rdf).The blood and reveos system appears normal based on run data file (rdf) data.The contamination could be related to factors that occurred after processing and during rbc filtration.A disposable complaint history search was performed for this lot and found two reports for similar issues on this lot.One similar report was below the reportable limit.The customer returned four used reveos lr sets containing blood throughout for investigation.The frangibles were sufficiently broken on each set and the blue clamps were in the open position.Each filter was noted to be full of blood on one side and dry on the other and no occlusions were identified when flow tested.The device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.Root cause: a root cause assessment was performed for this complaint.Root cause cannot be determined from the d-log.The blood and reveos system appears normal based on d-log data.The contamination could be related to factors that occurred after processing and during rbc filtration.
 
Event Description
The customer would like the run data file investigated to determine a possible cause for the elevated white blood cell (wbc) content in the red blood cell (rbc) product.There was not a transfusion recipient or patient involved at the time of the residual wbc testing, therefore no patient information is reasonably known at the time of the event.Donor unit id: (b)(6) the collection set is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.
 
Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10.Corrected information is provided in b.5.Investigation: the run data file (rdf) was analyzed for this event.Root cause cannot be determined from the run data file (rdf).The blood and reveos system appears normal based on run data file (rdf) data.The contamination could be related to factors that occurred after processing and during rbc filtration.A disposable complaint history search was performed for this lot and found two reports for similar issues on this lot.Both similar reports were below the reportable limit.The customer returned four used reveos lr sets containing blood throughout for investigation.The frangibles were sufficiently broken on each set and the blue clamps were in the open position.Each filter was noted to be full of blood on one side and dry on the other and no occlusions were identified when flow tested.The device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.Investigation is in process, a follow-up report will be provided.
 
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Brand Name
REVEOS AUTOMATED WHOLE BLOOD PROCESSING SYSTEM
Type of Device
REVEOS LR CPD/SAGM 450ML SYM W/ARM
Manufacturer (Section D)
TERUMO BCT, LTD
larne CO BT40 25H
UK  BT40 25H
Manufacturer (Section G)
TERUMO BCT, LTD
old belfast road
larne BT40 25H
UK   BT40 25H
Manufacturer Contact
dominique lefevre
old belfast road
larne BT40 -25H
UK   BT40 25H
MDR Report Key18519082
MDR Text Key333128763
Report Number3001980567-2024-00002
Device Sequence Number1
Product Code KSR
Combination Product (y/n)N
Reporter Country CodeNO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 01/16/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number54FG456S01
Device Lot Number230216B251
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/26/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/16/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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