MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLATELET SAMPLER PLASMA AUTO RBC SET

Model Number	80360
Health Effect - Clinical Codes	Reaction (2414); Loss of consciousness (2418)
Date of Event	01/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: according to aabb technical manual 16th edition, adverse events 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 3400 donors.(see sqs attachment pgs 195-196).Investigation is in process.A follow-up report will be provided.
Event or Problem Description
The customer reported that during a donation procedure, a donor started to experience intense leg cramps, the experienced a brief loss of consciousness (about 10-20 seconds).The donor hit his head on the donor bed when he passed out.The staff administered first aid and gave the donor fluids by mouth.The donor was released from the donor room and went home.The next day the staff followed up with the donor.He still complained of a headache, so they suggested that the donor go to the er for follow up.The customer stated that the donor was diagnosed with a mild concussion.The donor was released from the er.The staff followed up after his release and stated he was doing ok and no follow up was necessary.Donor is currently in stable condition.The customer declined to provide patient (donor) age.The disposable 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.10.Investigation: a disposable history search found no other reports of a similar issue associated with this lot.The device history record (dhr) was reviewed for this lot.There were no issues noted in the dhr that would have contributed to the donor reaction as experienced by the customer.Root cause: 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.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL LRS PLATELET SAMPLER PLASMA AUTO RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9830623
• Report Number: 1722028-2020-00111
• Device Sequence Number: 2611921
• Product Code: GKT
• UDI-Device Identifier: 05020583803602
• UDI-Public: 05020583803602
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2020

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: 11/01/2021
• Device Model Number: 80360
• Device Catalogue Number: 80360
• Device Lot Number: 1911052130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 04/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Weight: 106