MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA PLT, AUTOPAS, PLS, AUTORBC SET

Model Number	82470
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	10/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that around 40 minutes into a donor's first apheresis donation, the donor presented with general malaise, "burning with inspiration", respiratory difficulty, rash that started in the thorax and spread to the neck and upper limbs.The donation was suspended.The emergency system was activated and a few minutes later the donor was treated with crystalloids, adrenaline im 1mg, dexamethasone im 8mg and hydrocortisone iv 300mg and showed improvement in symptoms.She was transferred to the health center, under the diagnostic impression of anaphylactic reaction.Per the customer, the patient is stable and in good general condition without sequelae.No issues were noted with the procedure.Full patient id: cc (b)(6) the set is not available for return for evaluation.
Additional Manufacturer Narrative
Investigation: per the customer, 1000mg of calcium carbonate was administered approximately 20 minutes before the procedure.Investigation is in process.A follow up report will be reported.
Event or Problem Description
The customer reported that around 40 minutes into a donor's first apheresis donation, the donor presented with general malaise, "burning with inspiration", respiratory difficulty, rash that started in the thorax and spread to the neck and upper limbs.The donation was suspended.The emergency system was activated and a few minutes later the donor was treated with crystalloids, adrenaline im 1mg, dexamethasone im 8mg and hydrocortisone iv 300mg and showed improvement in symptoms.She was transferred to the health center, under the diagnostic impression of anaphylactic reaction.Per the customer, the patient is stable and in good general condition without sequelae.No issues were noted with the procedure.Full patient id: (b)(6).The set is not available for return for evaluation.
Additional Manufacturer Narrative
Investigation: per the customer, 1000mg of calcium carbonate was administered approximately 20 minutes before the procedure.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 a disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.The device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the patient reaction experienced by the customer.Root cause: 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.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA PLT, AUTOPAS, PLS, AUTORBC 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: 15835208
• Report Number: 1722028-2022-00372
• Device Sequence Number: 5775747
• Product Code: GKT
• UDI-Device Identifier: 05020583824706
• UDI-Public: 05020583824706
• 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): 11/21/2022

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: 06/01/2024
• Device Model Number: 82470
• Device Catalogue Number: 82470
• Device Lot Number: 2206161130
• 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: 10/27/2022
• Supplement Date Received by Manufacturer: 01/16/2023
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2022
• 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; Other
• Patient Age: 27 YR
• Patient Sex: Female
• Patient Weight: 65 KG