MAUDE Adverse Event Report: TERUMO BCT IMUGARD; IMUGARD WB PLT PLATELET POOLING SET

Catalog Number	5419501
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process, a follow-up report will be provided.
Event or Problem 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 whole blood product.Per the customer, their review of the run log showed there were no errors with the corresponding platelets that were in the pool.They also performed a visual inspection of the filter that was used during the platelet pooling process and there were no abnormalities observed.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.Terumo bct is awaiting return of the disposable set for evaluation.
Event or Problem 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 whole blood product.Per the customer, their review of the run log showed there were no errors with the corresponding platelets that were in the pool.They also performed a visual inspection of the filter that was used during the platelet pooling process and there were no abnormalities observed.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.
Additional Manufacturer Narrative
This report is being filed to provide additional information in d.4, h.6 and h.11.Investigation: a used platelet pooling assembly was returned for investigation.It was noted that the filter had clumping and clotting throughout.The filter was flow tested and passed.The fluid was able to flow freely through the filter assembly.A disposable complaint history search was performed for this lot and found no other report for similar issues on this lot.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 could not be determined but it is likely due to one or a combination of the possible causes listed below: * variation in manual expression steps of the platelet production process * the filter housing and/or membrane is physically damaged * donor physiology.
Additional Manufacturer Narrative
This report is being filed to provide additional information in b5, d9, h3, h6 and h11.Investigation: a used platelet pooling assembly was returned for investigation.It was noted that the filter had clumping and clotting throughout.The filter was flow tested and passed.The fluid was able to flow freely through the filter assembly.A disposable complaint history search was performed for this lot and found no other report for similar issues on this lot.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.
Event or Problem 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 whole blood product.Per the customer, their review of the run log showed there were no errors with the corresponding platelets that were in the pool.They also performed a visual inspection of the filter that was used during the platelet pooling process and there were no abnormalities observed.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.

• Brand Name: IMUGARD
• Common Device Name: IMUGARD WB PLT 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 Key: 23647693
• Report Number: 1722028-2025-00259
• Device Sequence Number: 21322533
• Product Code: KSR
• UDI-Device Identifier: 05020583419506
• UDI-Public: 05020583419506
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: BK230838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 5419501
• Device Lot Number: 2410021151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: 12/11/2025; 12/24/2025
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 12/18/2025; 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown