MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMALRS PLATELET PLASMA RBC AUTOPAS SET

Model Number 82410

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Low White Blood Cell Count (4433); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/20/2020

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Article citation: zhao j, gabriel e, norda r, et al.Frequent platelet donation is associated with lymphopenia and risk of infections: a nationwide cohort study.Transfusion.(b)(6) 2020.Https://doi.Org/10.1111/trf.16175 investigation is in process.A follow-up report will be provided.

Event Description

According to the article, "frequent platelet donation is associated with lymphopenia and risk of infections: a nationwide cohort study", a study found that 30% of frequent plateltpheresis donors had severe t-cell lymphopenia (<200x10^6 cellls/l), which persisted for at least a year after ceasing donations.The findings were rerported using trima accel with a leukoreduction system (lrs) chamber.According to the article, "the clinical significance of plateletpheresisassociated lymphopenia is unclear, and there are no studies addressing long-term health effects of repeated lymphocyte depletion in plateletpheresis donors." for common bacterial infections, there was an increased risk for infections only among most frequent donors with more 50 donations (hr, 2.5; 95% ci, 1.2-4.9).Events were rare, with only five events (4.6/1000 person-years) for the most frequent donors with more than 90% lrs donations.For immunosuppression-related infections, no statistical difference could be found; among most frequent donors.Patient details, including patient information and outcomes are not available.The article was based on a past study and did not include patient details, therefore this report is being provided as a summary of the events.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: per the article: study design and methods: a nationwide cohort study using the scandat3-s database was conducted with all platelet- and plasmapheresis donors in sweden between 1996 and 2017.A cox proportional hazards model, using donations as time- dependent exposures, was used to assess the risk of infections associated with plateletpheresis donations using an lrs chamber.Results: a total of 74408 apheresis donors were included.Among donors with the same donation frequency, plateletpheresis donors using an lrs chamber were at an increased risk of immunosuppression-related infections and common bacterial infections in a dose-dependent manner.While very frequent donors and infections were rare in absolute terms resulting in wide confidence intervals (cis), the increased risk was significant starting at one-third or less of the allowed donation frequency in a 10-year exposure window, with hazard ratios reaching 10 or more.No plateletpheresis donors that used an lrs chamber experienced a pneumocystis jirovecii, aspergillus, disseminated mycobacterial, or cryptococcal infection.In a subcohort (n = 42), donations with lrs were associated with low cd4+ t-cell counts (pearson's r = -0.41; 95% ci, - 0.63 to -0.12).Conclusion: frequent plateletpheresis donation using an lrs chamber was associated with cd4+ t-cell lymphopenia and an increased risk of infections.These findings suggest a need to monitor t-lymphocyte counts in frequent platelet donors and to conduct future investigations of long-term donor health and for regulators to consider steps to mitigate lymphodepletion in donors.During the study the authors provided evidence of an increased risk of infections among frequent plateletpheresis donors using an lrs chamber in a dose-dependent manner.The results are in line with the a priori hypothesis based on the observation of lymphopenia in frequent plateletpheresis donors using an lrs chamber.This is the believed to be the first study that has systematically assessed long-term health effects of lymphocyte reduction in plt donors.Zhao et al.Observed that among donors with the same donation frequency, plateletpheresis donors whose donations used an lrs chamber were at slight increased risk of infection compared to plasmapheresis donors.There was a modest increased risk for common bacterial infections only among most frequent donors with more than 50 donations during the study period.However, bacterial infections observed in the study were very rare (e.G., 4.6 common bacterial infections per 1000 person-years).There was no statistical difference for immunosuppression-related infections with most infections attributed to reactivation of varicella-zoster (shingles).In summary, the incidence rates of infections were low, resulting in wide confidence limits; health hazard risks should be interpreted with caution.For trima accel users concerned with potential leukopenia associated with frequent plateletpheresis, blood centers can enable the plasma rinseback feature on trima accel.According to internal studies, plasma rinseback can return up to 74% of wbcs to the donor compared to standard rinseback.Plasma rinseback is available on all commercialized software versions and adds less than five minutes at the end of the procedure for trima accel 7.According to an internal investigation, plasma rinseback was configured off for trima accel procedures included in the gansner study.Terumo blood and cell technologies does not have data on file for the entire period of the zhao study; however, it appears that almost 70% of blood centers in sweden had plasma rinseback configured off during the last year of the study.The customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.Root cause: a definitive root cause for the donor lymphopenia could not be determined.Possible causes include but are not limited to: - using standard rinseback instead of enabling plasma rinseback feature on trima accel - low t-lymphocyte counts as thymic output declines with age - donors physiology and other risk factors for infections.

Event Description

Pursuant to eu personal data privacy laws, the patient information is not available from the customer.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMALRS PLATELET PLASMA RBC AUTOPAS SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 11003387
• MDR Text Key: 242862973
• Report Number: 1722028-2020-00545
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583824102
• UDI-Public: 05020583824102
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2020

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 Model Number: 82410
• Device Catalogue Number: 82410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 12/14/2020
• Supplement Dates Manufacturer Received: 12/17/2021
• Supplement Dates FDA Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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