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Notifications on adverse reactions and events

​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.

If a serious adverse reaction or event is suspected, a notification shall be made to the Blood Service's Blood Safety Office, which reports these further to the authorities (the Finnish Medicines Agency Fimea). Any mild adverse reactions can also be filed on the same forms.

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's address:

Finnish Red Cross Blood Service (FRCBS)
Blood Safety Office
Kivihaantie 7
00310 Helsinki

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

  • The blood preparation suspected as the cause of an adverse reaction and the relevant transfusion equipment is stored for 24 hours sealed in a disposable plastic bag in refrigerator temperature (+2–+6°C) for potential further examination.
  • The preparation is always sent to the Blood Service as cold storage transportation (<10°C).
  • No samples should be taken of the preparation to avoid contamination.
    o 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 product is suspected, blood samples shall be taken from the patient for blood culture testing. They are examined in accordance with the hospital's normal procedure.


Delivery address for blood samples
Finnish Red Cross Blood Service (FRCBS)
Order Centre/preprocessing of samples
Kivihaantie 7
00310 Helsinki

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)


 

​Adverse reaction forms:

Notification on an adverse reaction or blood transfusion error (FI)
Notification on an adverse event (FI)


The Blood Service provides counselling and helps hospitals investigate adverse reactions and events related to blood transfusions.

Blood Safety Office
tel. +358 29 300 1100 , fax +358 29 300 1607
veriturva(at)veripalvelu.fi