MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL AUTORBC, PLASMA SET

Model Number	82520
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); Rash (2033); Tinnitus (2103); Respiratory Insufficiency (4462)
Date of Event	05/17/2023
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 25 minutes after starting apheresis the donor began to present redness on the face, arms, shoulders, and neck, and reported that the donor was also itching and had a sensation of heat along with mild shortness of breath and tinnitus.Loratadine was administered orally and the donor vomited and then 100mg of hydrocortisone was administered intravenously and a 10mg dose of loratadine was repeated orally.The customer reported that the symptoms began to subside after 5 minutes.The customer reported after 24 hours the donor reported a generalized slightly itchy rash and it was indicated that 10 mg of cetirizine was taken.The patient is in stable condition.Patient id and weight are not available at this time.The 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.4, b.5, h.6 and h.10.Investigation: a disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.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.Root cause: a root cause assessment was performed for this complaint.A definitive root cause for the donor's reaction could not be determined.Possible causes for the alleged reaction include but are not limited to donor's physiology and/or donor's sensitivity to the procedure.
Event or Problem Description
The customer reported that 25 minutes after starting apheresis the donor began to present redness on the face, arms, shoulders, and neck, and reported that the donor was also itching and had a sensation of heat along with mild shortness of breath and tinnitus.Loratadine was administered orally and the donor vomited and then 100mg of hydrocortisone was administered intravenously and a 10mg dose of loratadine was repeated orally.The customer reported that the symptoms began to subside after 5 minutes.The customer reported after 24 hours the donor reported a generalized slightly itchy rash and it was indicated that 10 mg of cetirizine was taken.The patient is in stable condition.The customer declined to provide the customer identifier.The collection set is not available for return because it was discarded by the customer.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL AUTORBC, PLASMA 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: 17130050
• Report Number: 1722028-2023-00212
• Device Sequence Number: 12621043
• Product Code: GKT
• UDI-Device Identifier: 05020583825208
• UDI-Public: 05020583825208
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2023

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: 12/01/2024
• Device Model Number: 82520
• Device Catalogue Number: 4825202
• Device Lot Number: 2212231142
• 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: 05/23/2023
• Supplement Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/23/2022
• 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: Required Intervention
• Patient Age: 23 YR
• Patient Sex: Female
• Patient Weight: 80 KG