MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA COLLECT SET

Model Number	12120
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930)
Date of Event	08/31/2020
Type of Reportable Event	Serious Injury
Additional 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.2020;1¿10.Https://doi.Org/10.1111/trf.16175 investigation is in process.A follow-up report will be provided.
Event or Problem 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.Tone site from the study used spectra optia with a leukoreduction system (lrs) chamber.According to the article, "the clinical significance of plateletpheresis associated 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.
Additional Manufacturer Narrative
Investigation: per the article, "blood services in sweden are part of the public health care system.Plateletpheresis and plasmapheresis donors are allowed to donate up to 24 times a year, which is regulated by the swedish board of health and welfare.The maximum volume allowed per plt donation is 600 ml for donors weighing more than 80 kg; 550 ml for donors weighing more than 50 kg; or 16% of the donors' blood volume calculated based on sex, height, and weight.Plateletpheresis donors are deferred if plt counts are less than 150 × 109/l, unless approved by the inhouse physician at the blood collection center.In the national regulations from 1989 to 2006, there was no formal restriction on the number of plateletpheresis donations other than that they had to be spaced 24 hours apart.The restrictions on apheresis donation frequency have otherwise remained the same throughout the study period.Plateletpheresis donors routinely donate 1 to 2 units but can donate up to 3 units per session.Results: a total of 74,408 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)." since this was a retrospective nationwide cohort study to assess the risk of infections associated with plateletpheresis donations using an lrs chamber involving a total of 74,408 apheresis donors in sweden between 1996 and 2017, the lot numbers are unknown; therefore, a dhr search could not be conducted for the reported incident.All lots must meet acceptance criteria for release.Root cause: a definitive root cause could not be determined.Possible causes include but are not limited to: - using standard rinseback instead of enabling plasma rinseback feature - low t-lymphocyte counts as thymic output declines with age - donors physiology and other risk factors for infections.
Event or Problem Description
This was a retrospective nationwide cohort study to assess the risk of infections associated with plateletpheresis donations using an lrs chamber involving a total of 74,408 apheresis donors in sweden between 1996 and 2017 (52% male, 48% female with a mean age of 32.7 years).A request for specific patient information is not feasible.

• Brand Name: SPECTRA OPTIA
• Common Device Name: SPECTRA OPTIA COLLECT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 11057358
• Report Number: 1722028-2020-00565
• Device Sequence Number: 3207197
• Product Code: GKT
• UDI-Device Identifier: 05020583121201
• UDI-Public: 05020583121201
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: BK150251
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2020

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
• Operator of Device: Health Professional
• Device Model Number: 12120
• Device Catalogue Number: 12120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Sex: Unknown