Reporting an adverse event

Reporting

The adverse reaction is reported using the form below. The notification and the product that caused the adverse reaction should be delivered to your own hospital laboratory/blood centre as soon as possible for further investigations.

The adverse reaction and event reports can be filled out electronically, but for privacy reasons, the forms should be sent by mail from the blood center to the Blood Safety Office or through the https://lomake.veripalvelu.fi/ service.

In case of suspected serious adverse reaction or if a patient has received an incorrect blood transfusion, the blood centre should forward the notification to the Blood Service’s Blood Safety Office as soon as possible. Incidents related to the quality and safety of the blood product should also be reported to the Blood Safety Office immediately, but near-miss situations related to transfusion activities can be reported according to the respective protocol of the healthcare unit, such as the HaiPro system. The blood centre may either submit reports of mild adverse events to the Blood Safety Office at the end of the calendar year or forward individual reports to the Blood Safety Office immediately after the incident has occured.

The Blood Safety office reports serious adverse reactions and events further to the authorities (The Finnish Medicines Agency Fimea).

Adverse reaction samples – storage and shipping

The healthcare unit can conduct the necessary investigations to determine the adverse reaction or request examinations from the Blood Service’s Blood Safety Office using the Adverse Reaction Notification Form. The Blood Service does not invoice for transfusion adverse reaction investigations.

Blood Product

• Each transfused blood product should be stored, along with its transfusion equipment, in a disposable plastic bag, refrigerated at temperatures between +2°C and +6°C, for 24 h for potential investigations.
• Compatibility testing segments removed from red blood cell products should be stored in the refrigerator for three days after the transfusion. The patient’s identification information as well as the unit number of the transfused product should be marked on them.
• The product should always be sent to the Blood Service under refrigerated transport (<10°C).
• Samples should not be taken from the product to avoid contamination.
• If the product has already been discarded, its contamination cannot be confirmed or ruled out in cases of severe fever reaction. Serological tests can be performed on compatibility testing segments.

Patient Samples

• A crossmatch sample or other blood sample taken before the blood transfusion, as well as a sample taken after the transfusion (2 x 7ml EDTA tubes). Sample collection should be ordered according to the hospital’s guidelines. If needed, seek advice from your own blood centre.
• If bacterial contamination of the product is suspected, blood culture samples should be taken from the patient. They are examined according to the hospital’s normal practices.
• You can find information about hospital-based examinations related to hemolysis and severe allergic reactions/anaphylaxis in the provided links in Finnish.

Possible side effects of OctaplasLG®

OctaplasLG® is a medicinal product. The healthcare unit should report any serious adverse reactions related to the medicinal product to the Finnish Medicines Agency Fimea.

Alternatively, hospitals can report the adverse effects caused by OctaplasLG® to the Blood Service’s Blood Safety Office. The Blood Safety Office will forward the notifications of OctaplasLG® adverse events to the marketing authorization holder (Octapharma).

Confirmation Notification

Once the investigation results of a serious adverse event are completed, a confirmation notification should be sent to the authorities. The Blood Service takes care of the confirmation notification unless otherwise agreed with the healthcare unit.