In this study we analyzed 12 years of adverse events, (AE) data from the World Apheresis Association, (WAA) Registry specific to the Spectra Optia Apheresis System. We queried WAA Registry data, (2012-2023) on apheresis procedures performed exclusively on the Spectra Optia Apheresis System. We categorized AEs by severity, (mild, moderate, and severe), and ordered them by year. We then analyzed and presented AEs associated with the following variables: diagnosis, procedure type, vascular access, and replacement fluid type, and causes of procedural interruption. We identified 51 567 apheresis procedures specific to the Spectra Optia Apheresis System within the data set. AE rates from 2012 to 2023 for mild, moderate, and severe were 1.43%, 2.81%, and 0.21%, respectively. Procedures associated with the lowest AE rates include red blood cell exchange and therapeutic plasma exchange. The most common mild and moderate AEs include tingling and hypotension and AEs related to vascular access. The highest rates of mild and moderate AEs were associated with cellular collections. The highest rate of severe AEs was associated with the use of 3.5% albumin as replacement fluid. Other variables impacting patient safety are identified. AE rates could not be compared to the median length of procedure since this time variable is not currently collected in the Registry. This is the first device-specific analysis of the WAA Registry data, bringing prior safety reporting into even sharper focus. Device-specific safety analysis like this will help practitioners better understand potential safety concerns associated with a commonly used apheresis device, including various separation modalities and accessories, thus supporting improved procedure management.

Apheresis Center University Hospital Orebro Sweden

Apheresis Department Institute of Hematology and Blood Transfusion Prague Czech Republic

AZ Delta Roeselare Belgium

Bone Marrow Transplant and Apheresis Apheresis and Cell Therapies Unit Concord Repatriation General Hospital Concord Australia

Department for Pediatrics St Anna Kinderspital Medical University of Vienna Vienna Austria

Department of Clinical Immunology and Transfusion Medicine and Department of Biochemical and Clinical Sciences Linkoping University Linkoping Sweden

Department of Immunology and Transfusion Medicine Akershus University Hospital Lorenskog Norway

Department of Molecular Medicine and Haematology University of Witwatersrand Johannesburg South Africa

Department of Patient Access Terumo Blood and Cell Technologies Lakewood Colorado USA

Department of Public Health and Clinical Medicine Umea University Umea Sweden

Department of Transfusion Medicine and Transplantation Biology University Hospital Centre Zagreb Zagreb Croatia

School of Medicine University of Zagreb Zagreb Croatia

South African National Blood Service Johannesburg South Africa

The Northern Sweden Registry Center Region Vasterbotten Umea Sweden

Unit of Transfusion Medicine of Sanquin Blood Supply Sanquin Blood Supply Foundation in Amsterdam Amsterdam the Netherlands

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