MAUDE Adverse Event Report: TERUMO BCT COBE SPECTRA; COBE SPECTRA SN LRS SET, ISBT

Model Number	70400
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930); Low White Blood Cell Count (4433)
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.(b)(6) 2020; 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.The findings were rerported using cobe spectra 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.
Additional Manufacturer Narrative
This report is being filed to provide investigation: it was unclear if medical intervention was required for the lymphopenia.The article made no allegation of device malfunction.The article provides evidence of an increased risk of infections among frequent plateletpheresis donors using an lrs chamber but does not stratify the rates specifically for cobe spectra.Overall, the study shows that there was an increased risk for infections among frequent donors with greater than 50 donations when comparing donations solely using an lrs chamber donations solely without a lrs chamber."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.¿ dhr details: 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: - 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: COBE SPECTRA
• Common Device Name: COBE SPECTRA SN LRS SET, ISBT
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w.collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 11057393
• Report Number: 1722028-2020-00566
• Device Sequence Number: 16811123
• Product Code: GKT
• UDI-Device Identifier: 05020583704008
• UDI-Public: 05020583704008
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: BK080035
• 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: 70400
• Device Catalogue Number: 70400
• 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: 07/22/2022
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 07/29/2022
• 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