MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA PLT + SAMPLER, MULTIPLS, RBC

Catalog Number	4824162
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Itching Sensation (1943); Hot Flashes/Flushes (2153); Swelling/ Edema (4577)
Date of Event	04/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported that during a platelet procedure a first time automation donor had what appeared to be an allergic reaction while on the device.The patient became itchy, flushed, and reported that his tongue was swelling.The procedure was stopped, 911 was called, and the donor was sent to the hospital via ambulance.Per the customer no medical intervention was provided at the donation center.Patient outcome is unknown at this time the platelet collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
This report is being filed to provide additional information in b.5, h.6 and h.11.Investigation: a disposable complaint history search was performed for this lot and found zero further reports for a similar issue on this lot.According to aabb technical manual 20th edition, adverse reactions can occur at the time of donation or after the donor has left the blood center.In a comprehensive donor hemovigilance program reported by the american red cross, adverse reactions were reported for wb collections (b)(4), plateletpheresis (b)(4), and double rbc unit collections (b)(4), the vast majority of which were minor presyncopal reactions and small hematomas.Serious adverse reactions were slightly more common for wb collections (b)(4) compared with plateletpheresis (b)(4) and double rbc unit collections (b)(4), reactions that needed medical care after the donor left the donation site occurred in roughly (b)(4) donations.A population based european study found the rate of complications leading to long-term morbidity or disablement to be (b)(4) donations and (b)(4), respectively.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found zero further reports for a similar issue on this lot.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported that during a platelet procedure a first time automation donor had what appeared to be an allergic reaction while on the device.The patient became itchy, flushed, and reported that his tongue was swelling.The procedure was stopped, 911 was called, and the donor was sent to the hospital via ambulance.Per the customer no medical intervention was provided at the donation center.Per follow up from the customer, the donor was reported as okay.The platelet collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11.Investigation: a disposable complaint history search was performed for this lot and found zero further reports for a similar issue on this lot.According to aabb technical manual 20th edition, adverse reactions can occur at the time of donation or after the donor has left the blood center.In a comprehensive donor hemovigilance program reported by the american red cross, adverse reactions were reported for wb collections (349 in 10,000), plateletpheresis (578 in 10,000), and double rbc unit collections (538 in 10,000), the vast majority of which were minor presyncopal reactions and small hematomas.Serious adverse reactions were slightly more common for wb collections (7.4 in 10,000) compared with plateletpheresis (5.2 in 10,000) and double rbc unit collections (3.3 in 10,000).Reactions that needed medical care after the donor left the donation site occurred in roughly 3 in 10,000 donations.A population based european study found the rate of complications leading to long-term morbidity or disablement to be 0.5 in 10,000 donations and 0.23 in 10,000, respectively.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: a root cause assessment was performed for the allergic reactions.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: * hypersensitivity to the ethylene oxide used to sterilize the disposable set.* hypersensitivity to the components inside the disposable set.
Event or Problem Description
The customer reported that during a platelet procedure a first time automation donor had what appeared to be an allergic reaction while on the device.The patient became itchy, flushed, and reported that his tongue was swelling.The procedure was stopped, 911 was called, and the donor was sent to the hospital via ambulance.Per the customer no medical intervention was provided at the donation center.Per follow up from the customer, the donor was reported as okay.The platelet collection set is not available for return because it was discarded by the customer.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA PLT + SAMPLER, MULTIPLS, RBC
• 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: 21950927
• Report Number: 1722028-2025-00112
• Device Sequence Number: 15662453
• Product Code: GKT
• UDI-Device Identifier: 05020583824164
• UDI-Public: 05020583824164
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: BK190332
• 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,Followup
• Report Date (Section B): 05/02/2025

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: 4824162
• Device Lot Number: 2409162142
• 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: 04/09/2025
• Supplement Date Received by Manufacturer: 05/15/2025; 06/13/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 05/27/2025; 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2024
• 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 Age: 59 YR
• Patient Sex: Male