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

Catalog Number	5803002
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	11/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that during a procedure, the donor reported pain.The operator checked the puncture point but found nothing abnormal.Approximately 13 minutes later the donor suddenly shouted and immediately lost consciousness.The operator laid the donor down and administered emergency measures such as oxygen inhalation, pulse and blood pressure monitoring, and pressing the philtrum-philtra, but there was no improvement.The donor was in a "coma" and his heart rate was lower than normal, between 40 and 50 bpm.The donor regained consciousness later but was unstable on his feet.Hours later, the donor was sent to the hospital for emergency treatment, where biochemical tests, electrolyte tests, and mri scans were conducted, but no abnormalities were detected.The doctors in hospital infused saline and glucose into the donor.On the next day, the donor had fully recovered and remains in good health with no detected illnesses to this day.Prior to the procedure the patient was listed as a little nervous, but all other vitals were normal.The customer noted that there were no issues observed during the procedure.The customer declined to provide the donor's id 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 b.5, b.6, h.6 and h.11.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 68 ml with 53 mls to the donor, 2 mls in the plasma product and the remaining 13 mls in the kit.It was confirmed that the trima system operated as intended and there were no unusual events.Individual donor tolerance to citrate may be a contributing factor.It is recommended to monitor this donor's next few apheresis donations for reactions.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 no reports for similar issues on this lot worldwide.According to aabb technical manual 16th edition, adverse reactions seen at the time of donation or those reported later average about 3.5% of donations.Reactions that need medical care after the donor has left the donation site are seen in 1 in 34 donors.Vasovagal reaction complex includes dizziness, sweating, nausea, vomiting, weakness, apprehension, pallor, hypotension, and bradycardia.In severe cases, syncope and convulsions may be observed.The pulse rate is often low during vasovagal reactions while the rate is often high during volume depletion.Some donors with severe reactions or those with prolonged recovery times may need short-term observation, intravenous fluid administration in the emergency room, or both.Root cause: a specific root cause for the reported reaction could not be determined.The reported adverse reactions are common side effects of therapeutic apheresis procedures.They are typically caused by fluid shift, blood loss, length of the procedure, donor's sensitivity to the procedure and/or hemodynamic stress of the procedure.
Additional Manufacturer Narrative
Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported that during a procedure, the donor reported pain.The operator checked the puncture point but found nothing abnormal.Approximately 13 minutes later the donor suddenly shouted and immediately lost consciousness.The operator laid the donor down and administered emergency measures such as oxygen inhalation, pulse and blood pressure monitoring, and pressing the philtrum-philtra, but there was no improvement.The donor was in a "coma" and his heart rate was lower than normal, between 40 and 50 bpm.The donor regained consciousness later but was unstable on his feet.Hours later, the donor was sent to the hospital for emergency treatment, where biochemical tests, electrolyte tests, and mri scans were conducted, but no abnormalities were detected.The doctors in hospital infused saline and glucose into the donor.On the next day, the donor had fully recovered and remains in good health with no detected illnesses to this day.Prior to the procedure the patient was listed as a little nervous, but all other vitals were normal.Patient id is unknown at this time.The collection set is not available for return because it was discarded by the customer.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL PLT, PLASMA, ISBT 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: 21019210
• Report Number: 1722028-2024-00570
• Device Sequence Number: 4008666
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2024

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: 09/01/2025
• Device Catalogue Number: 5803002
• Device Lot Number: 2309095151
• 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: 12/02/2024
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2023
• 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 Age: 32 YR
• Patient Sex: Male
• Patient Weight: 75 KG