Transfusion medicine handbook

7. Adverse Effects of Transfusion

7.2 Reporting Adverse Reactions and Events

Serious or life-threatening acute reactions are rare but new or unexpected symptoms that appear while the patient is being transfused must not be overlooked, as they may be an early warning sign of a serious reaction.

Severe reactions are most likely to occur within 15 minutes of starting a transfusion. It is important to monitor the patient closely during this initial period and thereafter at regular intervals according to local hospital policy. Serious events should be discussed with a NZBS Transfusion Medicine Specialist/ Medical Officer, or specialist haematologist, for advice on further management of the patient, laboratory investigations and future transfusion requirements.

When evaluating patients with adverse reactions to immunoglobulins products, assess the rate of administration, the hydration status and the need for pre-medication (anti-histamines) prior to subsequent infusions. For more information about managing adverse events, including a possible change to the approved immunoglobulin product for a specific patient, please get in touch with an NZBS Transfusion Medicine Specialist/ Medical Officer.

Adverse reactions to blood components

If the patient experiences an adverse reaction during or following transfusion of a blood component, clinical staff must report this to the blood bank as soon as possible. NZBS supplies an Acute Transfusion Reaction (ATR) - Notification to Blood Bank form (https://www.nzblood.co.nz/assets/Transfusion-Medicine/PDFs/111F009.pdf) that has guidelines for the management of adverse transfusion reactions to assist clinical staff in the immediate care of the patient.

The completed form should be sent to the blood bank along with remnants of the transfused components and laboratory samples required for full investigation of the reaction. Refer to Table 10.1: Sample Requirements for Pretransfusion Testing for further information.

Adverse reactions to fractionated products

If the patient experiences an adverse reaction to a fractionated plasma product this must be reported to the blood bank as soon as possible. The NZBS Fractionated Blood Product Adverse Event Notification form (111F003) should be used for reporting and is available from the NZBS website or the Blood Bank. This should be completed with all relevant information and returned to the Blood Bank promptly.

In accordance with pharmacovigilance requirements, NZBS reports deidentified information about adverse reactions to fractionated products to the relevant manufacturer, for example CSL Behring. Where clusters of similar adverse reactions occur, these are reported to the New Zealand regulator, Medsafe.

Adverse events associated with transfusion

The blood bank should be notified as soon as possible if it is believed that the patient has received a wrong blood component or fractionated product, received one intended for another patient, that the transfusion did not meet requirements or that the transfusion was inappropriate. It should be noted that the patient may not always experience or show a ‘reaction’ in these situations.