MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA PLATELET+SAMPLER, PLASMA, RBC SET

Model Number 82446

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)

Patient Problems Hypersensitivity/Allergic reaction (1907); Local Reaction (2035)

Event Date 01/17/2021

Event Type  malfunction  

Event Description

A representative of the cerus corporation, shared a medwatch 3003925919-2021-00004 with a terumo bct associate during a conversation.The report is of a platelet collection at a (b)(6).The platelet was subsequently intercept treated on (b)(6) 2021.Then transfused and the pediatric recipient experienced a non-serious event of febrile non-hemolytic transfusion reaction'.Then on (b)(6) 2021, a positive culture result on a sample taken from the intercept platelet transfusion bag was reported to the patient's clinician.' it does not appear the bacterial contamination was previously reported to (b)(6), have alleged that the trima system played a role in the bacterial contamination.Full patient id: (b)(6) patient weight and outcome are unknown.The associated medwatch lists the patient reaction as 'non-serious' the collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

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

Event Description

A representative of the cerus corporation, shared a medwatch 3003925919-2021-00004 with a terumo bct associate during a conversation.The report is of a platelet collection at a versiti blood center of indiana.The platelet was subsequently intercept treated on (b)(6) 2021.Then transfused and the pediatric recipient experienced a 'non-serious event of febrile non-hemolytic transfusion reaction'.Then 'on (b)(6) 2021, a positive culture result on a sample taken from the intercept platelet transfusion bag was reported to the patient's clinician.' it does not appear the bacterial contamination was previously reported to terumo bct.Neither cerus, nor versiti blood center of indiana, have alleged that the trima system played a role in the bacterial contamination.Full patient id: (b)(6).Patient weight and outcome are unknown.The associated medwatch lists the patient reaction as 'non-serious' 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.The product was not returned and therefore an evaluation could not be conducted.The customer provided a run summary report listing the product information and alarms during the procedure.There were several 'draw pressure too low' alarms and the operator made several adjustments to decrease the draw flow rate.The procedure was completed and the product was labeled as leukoreduced.A disposable complaint history search was performed for this lot and found no other reports for similar issues on this lot.According to the aabb circular of information for the use of human blood components (revised 2017), febrile nonhemolytic reactions are typically manifested by a temperature elevation of >1c or 2f occurring during or within 4 hours after a transfusion and in the absence of any other pyrexic stimulus or active warming.Febrile reactions may occur in less than 1% of transfusion of leukocyte-reduced red cell components and about 5% of leukocyte-reduced apheresis platelet components.Febrile reactions occur more frequently in patients receiving non-leukocyte-reduced components and those previously "alloimmunized" by transfusion or pregnancy.Antipyretics usually provide effective symptomatic relief.Patients who experience repeated, severe febrile reactions may benefit from receiving leukocyte-reduced components.If these reactions are caused by cytokines in the component, prestorage leukocyte reduction may be beneficial.Root cause: a root cause assessment was performed for the febrile non-hemolytic transfusion reaction.The reported adverse events are common side effects of transfusion.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: the action of antibodies against white cells or the action of cytokines either present in the transfused component or generated by the recipient in response to transfused elements.Patients received non-leukocyte-reduced components.Patients were previously "alloimmunized" by transfusion.A root cause assessment was performed for the microbial contamination.The root cause was determined to be an operator error where the contaminants were inadvertently introduced post transfusion during testing.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA PLATELET+SAMPLER, PLASMA, RBC 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: 12778752
• MDR Text Key: 281535160
• Report Number: 1722028-2021-00355
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583824461
• UDI-Public: 05020583824461
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Model Number: 82446
• Device Catalogue Number: 82446
• Device Lot Number: 2009164151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2021
• Initial Date FDA Received: 11/09/2021
• Supplement Dates Manufacturer Received: 07/26/2022
• Supplement Dates FDA Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/02/2020
• 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
• Patient Age: 3 YR
• Patient Sex: Male