Background: Leukocyte reduction filters (LRF) and blood transfusion sets (BTS) are frequently used medical devices to prevent blood transfusion-related adverse reactions. This study attempted to analyze these medical devices related adverse events reported by an institution for 10 years and to understand the status of such reports in Korea and the United States (U.S.). Methods: From January 2013 to October 2022, adverse events reported at Soonchunhyang university Bucheon hospital (SCHBC) were analyzed. From 2016 to 2022, adverse events registered in the Korean Medical Device Information Portal and the Total Product Life Cycle (TPLC) database of the U.S. were collected and evaluated using the International Medical Device Regulators Forum (IMDRF) code for medical device problems, clinical signs, and symptoms or conditions. Results: A total of 12, 47, and 1,422 events were identified in SCHBC, Korea, and the U.S., respectively. The medical device problems reported in BTS included fluid leakage, breakage, disconnection, and no flow. In LRF, device or reagent problems, coagulation of device or device components, and filtration problems were reported. Most of the clinical signs and symptoms or conditions were not applicable (98.1%, 1,453/1,481), but hypotension and hemolysis were reported in LRF. Conclusion To improve the safety of transfusion-related medical devices such as LRF and BTS, proper attention needs to be paid to adverse events and all medical institutions should participate in the reporting of such events.The various adverse events and associated IMDRF codes included in this study would help enable reporting of adverse events and improve patient safety.

Background: The selective leukoreduction protocol (SLP) is limited in that patients who require it can be overlooked. We estimated SLP compliance (SLPC) using the Observational Medical Outcomes Partnership common data model (CDM). Methods: Patients were classified into eight groups: pre- and post-hematology disease (A and B), pre- and post-solid organ transplantation (C and D), solid cancer (E), immunodeficiency (F), anticancer therapy (G), and cardiovascular surgery (H). We examined the red blood cell (RBC) transfusion history from three hospital datasets comprising approximately three million patients over 20 years using CDM-based analysis. SLPC was calculated as the percentage of patients who received only leukoreduced RBCs in total patients transfused RBCs. Results: In total, 166,641 patients from three hospitals were enrolled in this study. From 2001 to 2021, SLPC in all groups, except H, tended to increase, although there were differences among the hospitals. Based on the most recent values (2017–2021), the SLPC in groups A, B, D, and G was maintained at ≥75% until 1,095 days before or after diagnosis or treatment. Groups E, F, and H had < 50% SLPC one day after diagnosis and treatment. Conclusions CDM analysis supports the review of large datasets for SLPC evaluation. Although SLPC tended to improve in most patient groups, additional education and monitoring are needed for groups that continue to show low SLPC.

LW antigens are expressed in higher intensities in D-positive blood cells than D-negative cells, which can result in false identification of anti-D in pretransfusion testing. Although several cases of anti-LW have been reported abroad, to the best of our knowledge, none have been reported in Korea. Herein, we report a case of anti-LW in a 58 year-old RhD positive patient with non-Hodgkin's lymphoma with a positive direct Coombs test and a suspicion of the presence of passive anti-D antibodies because of a history of intravenous immunoglobulin administration. However, during a 5-month follow up, the antibody was confirmed as anti-LW on grounds that it showed weakened reaction in dithiothreitol treated cells and enforced reaction in cord O+ cells when compared to the results from antibody identification panel cells.
Antibodies ; Blood Cells ; Coombs Test ; Dithiothreitol ; Follow-Up Studies ; Humans ; Immunoglobulins ; Korea ; Lymphoma, Non-Hodgkin ; Sensitivity and Specificity*

No abstract available.
Medical Identity Theft

BACKGROUND: Pretransfusion tests are essential for safe transfusions, but occasionally, part or all can be omitted when a transfusion is needed urgently in an emergency. The purpose of this study was to share the authors' experience of various pretransfusion test protocols in a tertiary referral hospital in Korea. METHODS: From July 2016 to June 2017, all transfusion cases at Samsung Medical Center were analyzed retrospectively. For each pretransfusion test protocol, the parameters regarding issue, return and disposal rate of blood products, occurrence of hemolytic transfusion adverse effect, and prescription frequency of each respective department and ordering site were analyzed. RESULTS: A total of 90,539 units of red blood cells, 24,814 units of fresh frozen plasmas, 24,758 units of single donor platelets, and 23,303 units of platelet concentrates were issued during the study period. Among them, 3.6%, 1.8%, 0.3%, and 0.4% of red blood cells, fresh frozen plasmas, single donor platelets, and platelet concentrates were issued according to the emergency transfusion protocols. When various pretransfusion test protocols were applied to issue blood products, there was no case in which an adverse hemolytic transfusion reaction was suspected. When compared with usual pretransfusion test protocol, all emergency transfusion protocols showed significantly higher return and wastage rates in red blood cells and fresh frozen plasmas. Platelets also had a higher return and wastage rate, but the difference was not significant. CONCLUSION: These results suggests that there is no different risk of adverse hemolytic transfusion reaction regardless the pre-transfusion protocols, but management about of the increased rate of return and wastage of blood products in emergency transfusions should be considered.
Blood Platelets ; Emergencies ; Erythrocytes ; Humans ; Korea ; Plasma ; Prescriptions ; Retrospective Studies ; Tertiary Care Centers* ; Tissue Donors ; Transfusion Reaction

No abstract available.
Asia* ; Blood Transfusion* ; Humans

Background: In ABO-incompatible (ABOi) solid organ transplantation, the minimization and management of isoagglutinin (IA) against donor ABO antigens between before and two weeks after transplantation is important for preventing hyper-acute rejection. Several factors that can affect the IA titer have been reported. This is the first study to evaluate whether there are IA titer differences between kidney transplantation (KT) and liver transplantation (LT) recipients. Methods: Thirty-eight KT and 32 LT type O recipients, who underwent ABOi KT or LT between March 2013 and March 2018, were enrolled consecutively. The IgM IA and IgG IA titers of the LT and KT recipients at different time points (initial, operation day [day-0], postoperative one week, four weeks, and one year) were evaluated. Results: The LT recipients showed higher initial IgG IA titers than the KT recipients (P=0.01). This higher titer in the LT recipients persisted during the critical phase (from before transplantation to postoperative one week). The IgG and IgM IA titers were similar in the KT and LT recipients at postoperative four weeks. Conclusion The difference in IA titer between the underlying diseases should be considered in the desensitization protocol before ABOi SOT.

Background: In ABO-incompatible (ABOi) solid organ transplantation, the minimization and management of isoagglutinin (IA) against donor ABO antigens between before and two weeks after transplantation is important for preventing hyper-acute rejection. Several factors that can affect the IA titer have been reported. This is the first study to evaluate whether there are IA titer differences between kidney transplantation (KT) and liver transplantation (LT) recipients. Methods: Thirty-eight KT and 32 LT type O recipients, who underwent ABOi KT or LT between March 2013 and March 2018, were enrolled consecutively. The IgM IA and IgG IA titers of the LT and KT recipients at different time points (initial, operation day [day-0], postoperative one week, four weeks, and one year) were evaluated. Results: The LT recipients showed higher initial IgG IA titers than the KT recipients (P=0.01). This higher titer in the LT recipients persisted during the critical phase (from before transplantation to postoperative one week). The IgG and IgM IA titers were similar in the KT and LT recipients at postoperative four weeks. Conclusion The difference in IA titer between the underlying diseases should be considered in the desensitization protocol before ABOi SOT.