MAUDE Adverse Event Report: TEURMO 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	05/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported elevated white blood cell (wbc) content in a pooled blood product.Donor unit id (b)(6) there was not a transfusion recipient or patient involved at the time of the unit processing, therefore no patient information is reasonably known at the time of the event.The collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
Investigation is in process, a follow-up report will be provided.
Additional Manufacturer Narrative
This report is being filed to provide additional information in d.4, e.1, h.6, and h.11 and a correction in b.3.Investigation: an investigation was conducted for the imugard platelet pooling set leukoreduction failure.The terumo bct field performance team visited the customer sites to observe the platelet manufacturing process, and more specifically the platelet pooling process using the imugard pooling sets.The focus of this visit was to observe the processes to identify any possible causes or contributing factors to the leukoreduction failures observed beginning in february of 2024 and peaking in may of 2024.Many of the events occurred in may, which was shortly before both preventive maintenance and calibration verification were due on the sysmex instrument used to measure wbcs for those products.A review of the device history record (dhr) for this lot showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.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: * cell counter calibration and performance during the month of may.* minor differences in product handling and sampling processes compared to more typical processes.* variation in manual expression steps of the platelet production process.* possible differences in processes between the platelet manufacturing sites.* a defective supplier component (filter).
Event or Problem Description
The customer reported elevated white blood cell (wbc) content in a pooled blood product.Donor unit id # (b)(6).There was not a transfusion recipient or patient involved at the time of the unit processing; therefore, no patient information is reasonably known at the time of the event.The collection set is not available for return because it was discarded by the customer.

• Brand Name: IMUGARD
• Common Device Name: IMUGARD WB PLT PLATELET POOLING SET
• Manufacturer (Section D): TEURMO 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: 20174056
• Report Number: 1722028-2024-00390
• Device Sequence Number: 17907003
• Product Code: KSR
• UDI-Device Identifier: 05020583419506
• UDI-Public: 05020583419506
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2024

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 Expiration Date: 05/31/2025
• Device Catalogue Number: 5419501
• Device Lot Number: 2305101151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: 01/21/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2023
• 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