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

Catalog Number 82446

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 07/21/2023

Event Type  malfunction  

Manufacturer Narrative

Lot number, manufacture and expiry date are not available at this time.Investigation is in process, a follow-up report will be provided.Kaufman, r.M., marks, d.C., flamand, y., acker, j.P., brown, b.F., olafson, c., marschner, s., pandey, s., papari, m., petraszko, t., serrano, k., ward, d., & bazin, r.(2023).Risk factors for t-cell lymphopenia in frequent platelet donors: the best collaborative study.Transfusion, 63(11), 2072¿2082.Https://doi.Org/10.1111/trf.17567.

Event Description

Per journal article "risk factors for t-cell lymphopenia in frequent platelet donors: the best collaborative study" by kaufman, r.M., marks, d.C., flamand, y., acker, j.P., brown, b.F., olafson, c., marschner, s., pandey, s., papari, m., petraszko, t., serrano, k., ward, d., & bazin, r.Per the article, severe t-cell lymphopenia of uncertain clinical significance has been observed in frequent apheresis platelet donors.Two commonly used plateletpheresis instruments are the trima accel, which uses a leukoreduction system (lrs) chamber to trap leukocytes and the fenwal amicus, which does not use an lrs chamber.Study design and methods: we performed an international, multicenter, observational study comparing t-cell populations in frequent platelet donors collected exclusively using the trima instrument (n = 131) or the amicus instrument (n = 77).Age- and sex-matched whole blood donors (n = 126) served as controls.Specific details, such as patient information and outcome, were not included in the article for these events, therefore this report is being provided as a summary of the events.It is unknown that this time if medical intervention was required for these events.The collection set is not available for return because it was discarded by the customer.

• 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: 18790749
• MDR Text Key: 337623680
• Report Number: 1722028-2024-00065
• Device Sequence Number: 1
• Product Code: GKT
• 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: Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 82446
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: No
• 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