Complications related to apheresis Allergic reactions Citrate reaction Allergy (local) Definition: Neuromuscular hyperactivity related to Definition: Red or irritated skin at the venipuncture site. reduced ionized calcium levels. Mechanism: Reaction caused by allergens or irritants in Mechanism: Infusion of citrate anticoagulant during solutions used for disinfection of the arm (such as iodine apheresis causes a fall in ionised calcium levels, leading or chlorhexidine) or in manufacture of the collection to neuromuscular hyperactivity. If untreated, symptoms set. Irritation may also occur due to application of the may progress to tetany and severe cardiac arrhythmias, adhesive bandage (bandage adhesive dermatitis). An including cardiac arrest. Operator error with mix up of allergic reaction to latex that may be in supplies such as saline and citrate bags may occur with some apheresis gloves may also occur. equipment, and lead to rapid citrate infusion. Signs and symptoms: Itching and redness at the Signs and symptoms: Numbness or tingling of lips, venepuncture site, the bandage site, or the entire skin Standard for Surveillance feelings of vibrations, numbness or tingling in the fingers, disinfection area. In a true allergic reaction, there may of Complications Related metallic taste, chills, shivering, light-headedness, be a raised rash or hives in these areas that may expand feeling of tightness, muscle twitching, rapid or slow to cover a larger area of the arm. The reaction may occur to Blood Donation pulse, shortness of breath. soon after donation or in the hours to days post-donation. Donor vigilance: monitoring Symptoms may progress to carpopedal spasms and Generalised allergic reaction (anaphylactic and improving safety for blood donors vomiting, and in severe reactions, to generalised muscle reaction) contractions (tetany), shock, irregular pulse and cardiac December 2014 arrest. Definition: Anaphylactic type reactions usually starting soon after the procedure is begun and may progress Haemolysis rapidly to cardiac arrest. The great majority of blood donors Definition: Donor red cells may be damaged, releasing Mechanism: Extremely rare reactions, attributed to donor experience no complications. By monitoring haemoglobin. sensitivity to ethylene oxide gas used to sterilize some complications, blood establishments can collection kits. Mechanism: There may be malfunctioning valves, kinks take measures to further reduce them. or obstruction of the tubing, incorrect installation of Signs and symptoms: Apprehension, anxiousness, equipment, or other equipment failures affecting the flushing, swelling of eyes, lips or tongue, cyanosis, extracorporeal circuit. Incompatible replacement fluids, cough, wheezing, dyspnea, chest tightness, cramps, Complications mainly such as dextrose D5W, may be used in error. nausea, vomiting, diarrhoea, tachycardia, hypotension, with local symptoms and altered mentation. Signs and symptoms: Pink or red plasma, blood in lines These complications are directly caused by the insertion or filter may appear dark. The donor may notice pink or of the needle. Some of these are mainly characterized by red urine after collection. Other serious complications occurrence of blood outside vessels, whereas others are related to blood donation mainly characterized by pain. Air embolism Major cardiovascular event (MCE) Definition: Air bubble introduced into the donor’s Complications mainly characterized by the circulation. occurrence of blood outside the vessels • Acute cardiac symptoms (other than myocardial Mechanism: Air may enter into the lines due to incomplete infarction or cardiac arrest) Haematoma (bruise) priming of lines, as a result of a machine malfunction or • Myocardial infarction defective collection kits or through incorrect manipulation Definition: A haematoma is an accumulation of blood in • Cardiac arrest the tissues outside the vessels. by staff. Air in the donor’s pulmonary circulation may • Transient Ischemic Attack occlude the pulmonary arteries in the lung and cause • Cerebrovascular accident Mechanism: The symptoms are caused by blood flowing cardiopulmonary symptoms. Air may pass to the arterial • Death out of damaged vessels and accumulating in the soft circulation through an atrial septal defect, and reduce tissues. For apheresis procedures, haematomas may blood flow to the brain. Reporting is encouraged of MCE or death from any cause also be caused by infiltration of the soft tissues by red up to 24 hours after donation, with an assessment of cells during the return phase of the procedure. Large Signs and symptoms: Bubbling sound or feeling at imputability. Only cases with definite, probable or the venipuncture site. Cough, dyspnea, apprehension, haematomas, particularly those in deeper layers of the possible imputability should be included in international forearm, put pressure on surrounding tissues and may sweating, chest pain, confusion, tachycardia, reporting. Major cardiovascular events, including death, hypotension, nausea and vomiting. contribute to other complications such as nerve irritation may occur in the hours after attending the collection and injury and more rarely compartment syndrome. Optional category: Infiltration centre for blood donation. This can occur without any relation to the donation (for deaths, this is described by Signs and symptoms: Bruising, discolouration, swelling Definition: Intravenous solute (saline solution) enters the term actuarial deaths). and local pain. Accumulation of blood in deeper tissues the extravascular tissues during volume replacement may result in more serious pain and pressure syndromes (generally only applicable to double red cell procedures). Other complications listed below. Mechanism: The needle is no longer positioned in the Other systemic reactions or complications that do Arterial puncture intravascular space, so fluids enter the surrounding not fit into the above, such as chest pain that may Definition:Arterial puncture is a puncture of the brachial tissues. have been investigated as angina, but was actually artery or of one of its branches by the needle used for musculoskeletal, or transmission of infection to a donor Signs and symptoms: Swelling of the tissues at the bleeding the donor. venipuncture site. through erroneous re-use of equipment. Mechanism: Because of the rapid blood flow, the risk of a large haematoma is increased and thereby risks of more serious pain and pressure syndromes listed below. Signs and symptoms: A lighter red colour than usual of the collected blood can be seen. The needle and tubing may appear to pulsate; the blood bag fills very quickly. Contact: There may be weak pain localized to the elbow region. www.isbtweb.org/working-parties/haemovigilance/

CONTINUED ON BACK Complications mainly Complications mainly Complications mainly with local symptoms (cont’d) with local symptoms (cont’d) with local symptoms (cont’d) Complications mainly characterized by the Localised infection/inflammation Other major blood vessel injury (cont’d) occurrence of blood outside the vessels (cont’d) Localised infection/inflammation Brachial artery pseudoaneurysm Definition: Inflammation along the course of a vein, Definition: Collection of blood outside an artery, Delayed bleeding (re-bleeding) - optional which may progress to localised infection several days contained by adventitia or the surrounding tissues alone. category after phlebotomy. There may be clotting in the vein. Mechanism: After a traumatic arterial puncture, blood Definition: Leakage of blood from the venipuncture site Mechanism: Tissue damage and introduction of surface may leak out of the artery and accumulate in the after the initial bleeding has stopped. bacteria into the deeper tissues with venepuncture. surrounding space. The superficial vein itself (thrombophlebitis) or the Mechanism: Re-bleeding may be related to pressure not Signs and symptoms: Pulsating mass in the arm. being applied to the correct location or for an adequate surrounding subcutaneous tissue (cellulitis) may be predominantly affected. May be accompanied by pain and paraesthesias. May duration, or premature removal of the bandage. After be preceded by a large hematoma following arterial the donor has left the clinic, re-bleeding may be related Signs and symptoms: Warmth, tenderness, local pain, puncture. to heavy lifting or strain to the donor’s arm. Donors on redness and swelling at the site of phlebotomy. The certain medications, such as autologous donors on site and the vein may feel tender, firm, and warm to the anticoagulants, may be at higher risk to re-bleed. touch. Fever may be present. Complications mainly with generalized symtoms: Signs and symptoms: Spontaneous recommencement of Optional split into 2 categories: bleeding from the venipuncture site, after pressure has vasovagal reactions been applied and the initial dressing has been removed, Thrombophlebitis: The redness, swelling, and tenderness Definition:A vasovagal reaction (VVR) is a general feeling or leaking through the dressing. extend along the course of the vein. of discomfort and weakness with anxiety, dizziness and Cellulitis: The redness, swelling and tenderness affect nausea, which may progress to loss of consciousness Complications mainly characterized by the soft tissues, and are not localised to the course of (faint). It is the most common acute complication related to blood donation. pain the vein. Mechanisms: Both physiologic and psychological factors Nerve injury/irritation Other major blood vessel injury may be important. The reaction is generated by the autonomic nervous system and further stimulated by Definition: Injury or irritation of a nerve These rare, serious conditions must always be medically psychological factors and the volume of blood removed, Mechanism: A nerve may be hit directly by the needle at diagnosed. relative to the donor’s total blood volume. insertion or withdrawal, or there may be pressure on a Deep venous thrombosis (DVT) Signs and symptoms: Usually several of the following: nerve due to a haematoma or inflammation of the soft discomfort, weakness, anxiety, light-headedness/ tissues. Include medically diagnosed cases, as well as Definition: Thrombosis of a deep vein in the donor’s dizziness, nausea, chills, sweating, vomiting, pallor, cases reported on the basis of documented ‘nerve’ type phlebotomy arm. hyperventilation, rapid or a slow pulse. Hypotension symptoms. Mechanism: Superficial venous thrombosis may progress and loss of consciousness (LOC) may occur and can Signs and symptoms: Radiating, often ‘electrical’ sharp into the deeper veins of the donor’s arm. DVT may also be accompanied by loss of bladder or bowel control or pain moving away from the venepuncture site, and/ rarely occur without previous signs and symptoms of convulsive movements. Reactions may occur before or paraesthesias such as tingling, burning sensations superficial thrombosis. An additional risk factor for phlebotomy (rare), during phlebotomy or immediately in the hand, wrist or shoulder area but away from the thrombosis, in particular, the use of oral contraceptives, after phlebotomy, when the donor stands up, in the venepuncture site. Symptoms may arise immediately may be present in these donors. refreshment area, or after the donor has left the when the needle is inserted or withdrawn. In cases collection site. Most reactions occur within 12 hours of associated with a haematoma, pain may not be apparent Signs and symptoms: Swelling and pain in the upper phlebotomy. Reactions accompanied by LOC carry a risk at the time and may start when the haematoma has arm. May be accompanied by symptoms of superficial of injury, particularly if they occur once the donor has left reached a sufficient size, some time after insertion of the inflammation and thrombosis (see above). the collection site (delayed vasovagal reactions). needle. Symptoms may be worse in certain positions or Vasovagal reactions are divided in two main subgroups: with certain arm motions. Rarely, weakness of the arm Arteriovenous fistula may develop. Definition: Acquired connection between the vein and • Without loss of consciousness (LOC) – the donor artery due to venepuncture lacerations. does not faint Optional split by duration of symptoms: • With loss of consciousness (LOC) – the donor Mechanism: A channel forms between the lacerated vein Symptoms resolving within 12 months: Symptoms faints for a period of time and artery immediately post-venepuncture, or in the usually resolve within days, but rarely may persist for healing process. May be related to arterial puncture. Optional subdivision for donors with LOC: months or become permanent. Signs and symptoms: Pulsating mass with a palpable • LOC < 60 seconds – without other signs and Symptoms lasting more than 12 months. thrill and associated bruit. The affected area may be symptoms Other Painful arm – optional category warm, and the distal part of the arm may be cool if • LOC ≥ 60 seconds – or with complications significant shunting of blood is present. The distal veins of convulsive movements, urinary or faecal Definition: Pain in the arm is the primary symptom, may be dilated and may pulsate. incontinence without the characteristics of nerve irritation outlined above, or the presence of a large hematoma or other Compartment syndrome Optional subdivision: defined complications that may be painful.. Definition: Increased intracompartment pressure leading • With injury – Injury caused by falls or accidents Mechanism: Pain may be related to tissue injury, possibly to muscle and soft tissue necrosis. in donors with a vasovagal reaction due to hematoma in the deeper tissues. • Without injury Mechanism: Blood may accumulate in the frontal deep Signs and symptoms: Pain in the arm, without areas of the forearm, closing small blood vessels and Optional subdivision: characteristics of nerve irritation. May be described resulting in muscle and nerve tissue necrosis. May be Location of reaction: as an ache or heaviness in the arm, similar to that related to arterial puncture. experienced after vaccination. Include all cases where • On collection facility* – Symptoms occurred Signs and symptoms: Painful arm, particularly on arm pain is the main symptom, unless a diagnosis of before donor has left the donation site movement; swelling, paresthesias and partial paralysis. nerve injury/irritation is suspected in the presence of • Outside collection facility – Symptoms occurred nerve type symptoms recognised by trained staff. after donor has left the donation site *In area within which staff can observe the donor and be responsible for the care of donors with complications.

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