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AUSTRALIAN HAEMOVIGILANCE REPORT
A report by the National Blood Authority Haemovigilance Advisory Committee
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APPENDIX III: DEFINITIONS OF DONOR ADVERSE EVENTS

Table 39: Definitions for 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.

Table 40: 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

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