Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO BCT IMUGARD WB PLT PLATELET POOLING SET; REVEOS PLATELET POOLING SET
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TERUMO BCT IMUGARD WB PLT PLATELET POOLING SET; 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 11/22/2023
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 pooled 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.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.
 
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 pooled 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.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: we confirmed that the information of the very high wbc levels as described in ¿issue¿ above.We then received filters, we performed the following investigations.Unit id: (b)(4).Normal saline was injected into the filter to check whether there was blockage and we confirmed that normal saline flowed through the filter at a rate of about 7.5 ml/min.After rinsing, we disassembled the filter to visually inspect the filter membranes and confirmed that the filter consisted of the main filter layers with three membranes, and it revealed no abnormalities.We observed the adhesion of blood in the first filter membrane from the inflow side of the filter.We dyed the filter membranes with toluidine blue and the results revealed that the first filter membrane from the inflow side was dyed darker.From the above-mentioned results, we inferred that air was included in the filter during pooling or that platelet aggregation was generated and caused to block the flow path of the filter membranes.Root cause: as mentioned in the investigation results above, we did not observe any abnormalities in the filter concerned and it was confirmed in the manufacturing record that the filter concerned was within the quality standards.We therefore infer that the issue reported was not caused by the filter.As the results of the analysis of the returned filters, we observed the adhesion of blood in the first filter membrane from the inflow side of each filter and the filter media were dyed darker with toluidine blue.Therefore, occlusion in the filter may have occurred due to the blood aggregates adhered to the filter media, and it resulted in a decrease of the filtration effective area.When the filtration effective area decreases, blood may be filtered by the filter area smaller than usual and it results in a fast linear speed (a flow rate per unit area) and possibly causes elevated rwbc level.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
IMUGARD WB PLT PLATELET POOLING SET
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 Key18373075
MDR Text Key331177758
Report Number1722028-2023-00419
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 12/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2023
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? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/30/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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;
-
-