MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL PLT,PLASMA,ISBT

Catalog Number	5803002
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Laceration(s) (1946)
Date of Event	11/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that after a double platelet procedure on a trima device, the donor acquired a nasal bone fracture.During the donor's second trip to the restroom, the donor fell, resulting in a nasal bone fracture.Additionally, due to wearing near-sighted glasses, the donor also sustained a scratch on the cheek below the eye.Medical intervention included debridement of the wound and suturing with over 20 stitches.The donor was discharged from hospital on (b)(6)2024.The platelet 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.
Event or Problem Description
The customer reported that after a double platelet procedure on a trima device, the donor acquired a nasal bone fracture.During the donor's second trip to the restroom, the donor fell, resulting in a nasal bone fracture.Additionally, due to wearing near-sighted glasses, the donor also sustained a scratch on the cheek below the eye.The donor status prior to the procedure was "normal".Medical intervention included debridement of the wound and suturing with over 20 stitches.The donor was discharged from hospital on (b)(6) 2024 and follow-up treatment for scar removal will be needed later.Donor id was not provided per confidentiality rules.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 a.2, a.3a, a.4, b.5, b.6, e.1, h.6, and h.11 and corrected information in e.1.Investigation: the run data file (rdf) was analyzed for this event.Review of the rdf showed that there were no events (alerts, adjustments, changes in pump speed, etc.) during the run that could have caused the reported donor reaction.The total amount of ac reported by the trima accel device was 258 ml, with 165 ml to the donor, 80 ml in the platelet product and the remaining 13 ml in the set.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 worldwide.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 (white blood cell) wb collections (349 in 10,000), plateletpheresis (578 in 10,000), and double (red blood cell) 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.Vasovagal reactions (also referred to as pre-faint or presyncope) include dizziness, sweating, nausea, vomiting, weakness, apprehension, pallor, hypotension, and bradycardia.The reaction might progress to syncope (loss of consciousness); convulsions and loss of bladder and bowel function might also occur.Most reactions occur at the collection site, either in the donation chair or the recovery area, per aabb technical manual 20th edition.Root cause: a root cause assessment was performed for this complaint.A specific root cause for the reported reaction could not be determined.Vasovagal reactions are common side effects of apheresis donations.They are typically caused by a fluid shift, blood loss, length of the procedure, donor's sensitivity to the procedure and/or hemodynamic stress of the procedure.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL PLT,PLASMA,ISBT
• 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: 21079496
• Report Number: 1722028-2025-00010
• Device Sequence Number: 12845407
• Product Code: GKT
• UDI-Device Identifier: 05020583803008
• UDI-Public: 05020583803008
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2026
• Device Catalogue Number: 5803002
• Device Lot Number: 2405304251
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2024
• 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; Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 70 KG