When it is suspected that a blood product is causing an adverse reaction, the transfusion is immediately stopped and it is checked that the blood preparation in use was meant for the patient in question. It is also checked that the potentially exchanged blood preparation is not being erroneously administered to another patient.
Notification
Adverse reactions are reported to the hospital's own laboratory/blood centre using the forms found on the right-hand side of the webpage.
It is important to fill all the sections of the form carefully! The notification on adverse reactions and events can be filled in electronically, but for data protection reasons the form must be sent by mail to the Blood Safety Office.
If a serious adverse reaction or event is suspected, the hospital's laboratory/blood center should forward the notification and to the Blood Service's Blood Safety Office as soon as possible. Any mild adverse reactions can also be filed on the same form and forwarded to the Blood Safety office.
The Blood Safety office reports serious adverse reactions and events further to the authorities (the Finnish Medicines Agency Fimea).
Samples on adverse effects – storage and sending
An operational health care unit can conduct the necessary investigations of adverse reactions itself or, if it so wishes, request an investigation by the Blood Service's Blood Safety Office using a notification form of an adverse reaction. The Blood Service does not carry any charges on the investigation of adverse reactions to blood transfusion.
Blood preparation
- All blood components should be sealed in a plastic bag and stored for 24 hours after the transfusion in refrigerator temperature (+2–+6°C) for potential further examination.
- The blood component is always sent to the Blood Service as cold storage transportation (<10°C).
- No samples should be taken of the blood component to avoid contamination.
- If the red cell component has already been destroyed, the investigation can be performed on the pieces of tubes used for compatibility testing kept in the refrigerator, marked with the preparation's unit number (donation number) and patient information.
Patient samples
- A compatibility test sample or some other blood sample taken before the transfusion and 2 x 7ml EDTA collection tubes taken after the transfusion.
- When bacterial contamination of the blood component is suspected, blood samples should be taken from the patient for blood culture testing. They are examined in accordance with the hospital's normal procedure.
- When haemolytic transfusion reaction is suspected, the following should be examined in the hospital: B-PVKT, P-LD, P-Haptog, P-Krea, P-Bil, P-Bil-Kj, P-Hb and U-Hb, E-Coomb-O.
- When severe allergic reaction or anaphylaxis is suspected, the patient's IgA-level should be examined in the hospital laboratory from a sample taken before the blood transfusion. If necessary, the examination can also be done in by the Blood Service.
Potential adverse reactions to OctaplasLG® preparation
OctaplasLG® is a medicinal product. A nursing unit should report any serious adverse effects related to a medicinal product to Fimea (the Finnish Medicines Agency).
Alternatively, hospitals can report adverse reactions caused by OctaplasLG® to the Blood Service's Blood Safety Office. The Blood Safety Office takes care of informing the sales licence holder (Octapharma) of OctaplasLG® about any adverse reactions.
Confirmation notification
Once the investigation of a serious adverse reaction has been completed, the authority must send a confirmation notification using one of the forms below. The Blood Service will be responsible for the confirmation notification unless otherwise agreed with the operational health care unit.
Confirmation of an adverse reaction (FI)
Confirmation of an adverse event (FI)
