title: The German Haemovigilance System--reports of serious adverse transfusion reactions between 1997 and 2007.
abstract: Data of the German Haemovigilance System were collected from 1997 to 2007 and assessed on the basis of pre-defined safety standards. Suspected cases of serious adverse reactions following transfusions reported to the Paul-Ehrlich-Institut were evaluated on the basis of national criteria, and the definitions of International Society of Blood Transfusion (ISBT) in compliance with defined causality criteria. The suspected cases were rated as confirmed and unconfirmed transfusion reactions. Assessment of causality took into consideration the clinical course of the adverse reaction and, if necessary, information about donation and manufacturing. Of the 5128 suspected serious adverse reactions, 1603 could be confirmed. Referring to the absolute figures, acute transfusion reactions (e.g. allergic reactions, hypotension and dyspnoea) were recorded most frequently, followed by transfusion-related acute lung injury (TRALI), haemolytic reactions, transfusion-related bacterial infections and virus infections. The majority of the 52 transfusion-related fatalities (14 each) were due to TRALI and acute transfusion reactions (mostly severe allergic reactions). Referred to the blood products administered, immune TRALI cases and TRALI-related fatal courses were most frequently reported after administration of fresh frozen plasma (FFP) (15/10(6) and 3.5/10(6) units, respectively), transfusion-related bacterial infections after administration of platelet concentrates (7/10(6) units), acute haemolytic transfusion reactions after administration of red blood cell concentrates (2.3/10(6)units) and acute transfusion reactions after administration of red blood cell or platelet concentrates (7.8/10(6) and 13/10(6) units, respectively). Despite the high safety standard required for blood products in Germany, there is still room for reducing the frequency of isolated cases of transfusion reactions by targeted action.
authors.affiliation: Paul-Ehrlich-Institut, Division S: Safety of Medicinal Products and Medical Devices, Paul-Ehrlich-Strasse 51-59, 63225 Langen, Germany.
authors.forename: B
authors.initials: B
authors.lastname: Keller-Stanislawski
authors.forename: A
authors.initials: A
authors.lastname: Lohmann
authors.forename: S
authors.initials: S
authors.lastname: Günay
authors.forename: M
authors.initials: M
authors.lastname: Heiden
authors.forename: M B
authors.initials: MB
authors.lastname: Funk
mesh_terms: D001803:Blood Transfusion / Q000592:standards / Q000706:statistics & numerical data; D005069:Evaluation Studies as Topic; D005858:Germany; D006801:Humans; D019221:Mandatory Reporting; D011159:Population Surveillance; D012308:Risk Management; D065227:Transfusion Reaction