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

Model Number 82520

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Itching Sensation (1943); Rash (2033)

Event Date 04/28/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that during a the first donation by apheresis the patient started to present redness on the face, arms, shoulders, and neck and also reported itching and a sensation of mild heat.The customer reported that 100mg of hydrocortisone was administered intravenously and 10mg loratadine orally.The event was resolved in 1 hour and the donor is asymptomatic.The donor is in stable condition.Donor id is not available at this time.The collection set is not available for return because it was discarded by the customer.

Event Description

The customer reported that during a the first donation by apheresis the patient started to present redness on the face, arms, shoulders, and neck and also reported itching and a sensation of mild heat.The customer reported that 100mg of hydrocortisone was administered intravenously and 10mg loratadine orally.The event was resolved in 1 hour and the donor is asymptomatic.The donor is in stable condition.The customer declined to provide the patient identifier.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: 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 there was one other report of similar issues on this lot from the same customer.Review of the run data file showed that the collection of rbc product 1 started at 8 minutes and completed at 18 minutes.The ¿drbc split alert¿ notification was presented upon completion of rbc product 1.The collection of rbc product 2 started at 20 minutes and was aborted with rinseback by the operator at 26 minutes.The total amount of ac reported by the trima accel device was 149 ml with 125 mls to the donor, 11 mls in the two rbc products and the remaining 13 mls in the kit.The total amount saline administered to the donor reported by the trima accel device was 283.58 mls.There were no events (alerts, adjustments, changes in pump speed, etc.) during the course of the procedure that could have caused the reported donor reaction.No recommendations as this analysis was requested due to a donor reaction.It was confirmed the trima accel system operated as intended and there were no unusual events.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.A population based european study found the rate of complications leading to long-term morbidity or disablement to be 0.5 in 10,000 donations and 0.23 in 10,000, respectively.Root cause: a root cause assessment was performed for the allergic reactions.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
• Type of Device: 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: 17130676
• MDR Text Key: 317217794
• Report Number: 1722028-2023-00213
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 05/23/2023
• Initial Date FDA Received: 06/14/2023
• Supplement Dates Manufacturer Received: 06/30/2023
• Supplement Dates FDA Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/23/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 79 KG