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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO BCT REVEOS AUTOMATED WHOLE BLOOD PROCESSING SYSTEM; REVEOS PLATELET POOLING SET
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TERUMO BCT REVEOS AUTOMATED WHOLE BLOOD PROCESSING SYSTEM; REVEOS PLATELET POOLING SET Back to Search Results
Catalog Number 5419401
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 09/13/2023
Event Type  malfunction  
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 pooling 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.The platelet pooling 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
Investigation is in process, a follow-up report will be provided.
 
Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10.Investigation: a disposable complaint history search was performed and two reports for similar issues were identified on this lot.See mdr 1722028-2023-00419 for reportable event.All other events did not meet the criteria for reportable.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.Based on the available information, a definitive root cause for the reported rwbc results issue could not be determined at this time.Possible causes for these failures include, but are not limited to: the whole pooling set was hung in full length impeding the filtration process.The operator inadvertently not closing the clamp above the filter at the beginning of the pooling process.Leaving the clamp open allowed for platelets and or pas to partially wet or prime the filter.By not completely priming the filter and forcing the air out of the filter, the full surface area of the media will not be used during filtration, reducing the effective filtration area, and leading to the potential for elevated rwbcs in the pooled platelet.An unidentified manufacturing issue with the filter.Donor physiology may also contribute to a higher-than-expected level of wbcs.Based on the available information a definitive root cause for the reported slow filtration could not be determined but it is likely due to one or a combination of the possible causes listed below: characteristics of the blood being processed.Inadequate mixing of the blood.Incorrect storage temperature of whole blood prior to processing, or of platelets prior to filtration, can cause platelet aggregate formation which may potentially block the filter during 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 platelet pooling 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.The platelet pooling 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.
 
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Brand Name
REVEOS AUTOMATED WHOLE BLOOD PROCESSING SYSTEM
Type of Device
REVEOS PLATELET POOLING SET
Manufacturer (Section D)
TERUMO BCT
lakewood CO 80215
Manufacturer (Section G)
TERUMO BCT
10810 w. collins ave
lakewood CO 80215
Manufacturer Contact
scot hilden
10810 w. collins ave
lakewood, CO 80215
MDR Report Key18409666
MDR Text Key331502567
Report Number1722028-2023-00424
Device Sequence Number1
Product Code KSR
Combination Product (y/n)N
Reporter Country CodeSW
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
Report Date 12/28/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5419401
Device Lot Number2305251151
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/08/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/02/2023
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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