Appendix III: Definitions of donor adverse events

Table 40: Definitions of donor adverse events
Event Type	Definition
Vasovagal	Vasovagal reaction is a reflex of the involuntary nervous system that causes the heart to slow down whilst causing the blood vessels in the legs to dilate (expand). The widening of these blood vessels causes blood to pool in the legs, reducing the amount of blood being supplied to the brain. When the brain is deprived of oxygen, a fainting episode is likely to occur.
	Fainting is a loss of consciousness caused by a lack of blood supply to the brain, also known as syncope.
	Pre-faint refers to symptoms such as dizziness, sweating, muffled hearing and nausea that can result from a vasovagal reaction. If these symptoms do not progress to loss of consciousness, the reaction can be termed 'pre-faint' or 'pre-syncope'.
	Mild	A donor experiences symptoms lasting less than 15 minutes without fainting (loss of consciousness) or seizure.
	Moderate	A donor experiences symptoms lasting at least 15 minutes but less than 1 hour without fainting (loss of consciousness) or convulsions.
	Severe	A donor who faints experiencing loss of consciousness for ANY length of time with or without convulsions (seizures) or pre-faint symptoms that persist for more than 1 hour.
	Delayed	Donors who experience ANY of the signs and symptoms associated with vasovagal, pre-fainting and fainting ANYTIME AFTER they have left a Blood Service collection site. Events that occur in the refreshment area or bathroom of a Blood Service collection site are not classified as 'delayed'. There is a high rate of injury associated with delayed reactions as they can occur without warning up to 6 hours after the donation while the donor is travelling home, working or driving.
	Complicated	A donor experiences a fall or incident as a result of a vasovagal reaction causing injury. For example a donor may hit their head as they fall, lacerating their forehead and fracturing their jaw. These events can occur on- or off-site.
Haematoma	A bruise or haematoma is bleeding or a collection of blood under the skin. It is formed when blood leaks from the vein into the surrounding tissues. The following are reported: 5 centimetres in diameter or greater less than 5 centimetres in diameter, but associated with persistent pain or symptoms of nerve injury or irritation.
Arterial puncture	When a needle is incorrectly inserted into the artery instead of the vein.
Extravasation	Occurs when a large volume of blood or fluid leaks under pressure, out of the vein wall into the surrounding tissue and forearm.
Compartment syndrome	Develops when leaked blood or fluid compresses nerves, blood vessels and muscle. An increase in pressure results in the decrease of blood supply to the muscle and tissue leading to necrosis (tissue death).
Nerve injury	Direct nerve injury or trauma occurs when the needle cuts or damages the nerve or the sheath of the nerve. Indirect nerve injury, trauma or irritation is caused by pressure from a bruise/haematoma or swelling pushing against the nerve.
Post donation thrombosis	Thrombosis is the formation of a blood clot. Post-donation thrombosis is the formation of a blood clot in a deep vein (such as the axillary vein) with very little inflammatory reaction in the vein wall.
Thrombophlebitis	Phlebitis is inflammation of a vein. Thrombophlebitis is inflammation of a vein associated with the formation of a blood clot.
Serious	Any event that requires external referral to a hospital, general practitioner or any other registered medical practitioner.

Source: Blood Service 2013

Table 41: Alignment of events between Australian and international categories
Australian Category Description	Relevant International Category
Air Embolism	Air Embolism
Allergic Reaction Mild	Generalised Allergic Reaction
Allergic/Anaphylactic Reaction—Progressive to Severe	Generalised Allergic Reaction
Allergic/Anaphylactic Reaction—Severe	Generalised Allergic Reaction
Arterial Puncture	Arterial Puncture
Cardiac Arrest	Other
Chest Pain	Other
Citrate Toxicity—Mild	Citrate Reaction
Citrate Toxicity—Moderate	Citrate Reaction
Citrate Toxicity—Severe	Citrate Reaction
Death of Donor	Other
Delayed Bleeding	Delayed Bleeding
Suspected Haemolysis	Haemolysis
Extravasation of Fluid / Compartment Syndrome	Other
Haematoma	Haematoma
Local Allergy	Allergy (Local)
Nerve Injury	Nerve Injury
Nerve Irritation	Nerve Irritation
Not Reportable Event	Not Reportable Event
Omitted Anticoagulant—Moderate	Other
Omitted Anticoagulant—Severe	Other
Other Injury	Other
Painful Arm	Painful Arm
Post Donation Thrombosis—Axillary Vein Involvement	Other
Post Donation Thrombosis—No Axillary Vein Involvement	Other
Tendon Injury	Tendon Injury
Thrombophlebitis	Thrombophlebitis
Vasovagal Reaction—Mild	Immediate Vasovagal Reaction
Vasovagal Reaction—Mild & Delayed	Delayed Vasovagal Reaction
Vasovagal Reaction—Moderate	Immediate Vasovagal Reaction
Vasovagal Reaction—Moderate & Complicated	Immediate Vasovagal Reaction with Injury
Vasovagal Reaction—Moderate & Delayed	Delayed Vasovagal Reaction
Vasovagal Reaction—Moderate & Delayed & Complicated	Delayed Vasovagal Reaction with Injury
Vasovagal Reaction—Severe	Immediate Vasovagal Reaction
Vasovagal Reaction—Severe & Complicated	Immediate Vasovagal Reaction with Injury
Vasovagal Reaction—Severe & Delayed	Delayed Vasovagal Reaction
Vasovagal Reaction—Severe & Delayed & Complicated	Delayed Vasovagal Reaction with Injury
Wrong Solution Administered	Other

Source: Blood Service 2013