DIRECTIVE 2004/23/EC, article 3 (n)

‘serious adverse reaction’ means an unintended response, including a communicable disease, in the donor or in therecipient associated with the procurement or human application of tissues and cells that is fatal, life-threatening, disabling, incapacitating or which results in, or prolongs, hospitalisation or morbidity;

DIRECTIVE 2004/23/EC, article 3 (m)

‘serious adverse event’ means any untoward occurrence associated with the procurement, testing, processing, storage and distribution of tissues and cells that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for patients or which might result in, or prolong, hospitalisation or morbidity;

Anaphylactic reaction

Rapidly developing allergic reaction with onset from a few seconds after starting transplantation until soon after the end, with features such as in- and expiratory stridor, fall in systolic and/or diastolic blood pressure ≥ 20mm Hg, nausea or vomiting or diarrhoea, backache, skin rash.

Other allergic reaction

Allergic phenomena such as itching, local or generalised redness or urticaria with onset from a few minutes after starting transplantation until a few hours after completion but without respiratory, cardiovascular or gastrointestinal features.

Hemolytic reaction

Increased destruction of red blood cells occurring within a few minutes of commencement or up to a month following transplantation (usually: hematopoietic stem cells) manifested by one or more of the following: fall in systolic and/or diastolic blood pressure ≥ 20mm Hg, fever/chills, nausea/vomiting, backache, dark or red urine or unexplained drop in hemoglobin.

TRALI (transfusion-related acute lung injury)

Features of acute lung injury such as dyspnea and hypoxia during or within six hours following the transplantation (usually: hematopoietic stem cells); chest X-ray shows bilateral finely mottled pulmonary infiltrates.

Circulatory overload

Features of circulatory overload such as dyspnea, orthopnea, cyanosis, tachycardia >100/min and raised central venous pressure, developing during or within 6 hours after transplantation (usually: hematopoietic stem cells). Chest X-ray shows features consistent with circulatory overload.

Post-transplantation bacterial infection

Any case of (microbiologically confirmed) bacterial infection in a recipient of transplanted cells or tissues where the time interval or circumstances raised the suspicion of a connection with the transplantation.

Post-transplantation viral infection

Any case of microbiologically confirmed viral infection in a recipient of transplanted cells or tissues where the time interval or circumstances raised the suspicion of a connection with the transplantation.

Other post-transplantation infection

Any case of infection other than with a virus or bacteria, e.g. a parasitic infection or variant Creutzfeldt Jakob Disease) which has been demonstrated within a relevant time interval following transplantation of tissue and/or cells.

Post-transplantation malignancy

Demonstration of a malignant disease in the recipient within a relevant interval following transplantation of human tissues and/or cells, where a link with the transplantation is suspected.

Post-transplantation febrile reaction

Rise in temperature of ≥  2 o C and/or rigors/chills) during or in the first two hours after a transplantation with no other relevant symptoms or signs and with normalisation within 24 hours.

Other reaction

Any adverse reaction in a recipient of human tissue and/or cells which does not fit in one of the above categories. Example: neurological signs following infusion of peripheral blood stem cells.

Donation complication

An adverse reaction in a donor which occurs before, during or after donation of tissues or cells (e.g. splenic rupture, bacterial infection).

Bacterially contaminated product

Demonstration of a relevant quantity of bacteria in tissue and/or cells which have been distributed and may have already been transplanted,

State any reaction or consequences for the recipient in section 6 (“consequence/reaction”).

Virally infected product

Demonstration of a viral infection in tissue and/or cells which have been distributed and may have already been transplanted,

State in section 6 (“consequence/reaction”) whether the viral infection has also been demonstrated in the recipient.

Other infection of product

Demonstration of another type of infection (fungal, parasitic) in tissue and/or cells which have been distributed and may have already been transplanted,

State any reaction or consequences for the recipient in section 6 (“consequence/reaction”).

Risk of transmission of an other disease/ condition (formerly: product incident)

Any case where a potentially transmissible disease, other than a bacterial, viral, fungal or parasitic infection, has been demonstrated in the donor or in distributed or transplanted cells or tissue (e.g. malignancy, variant Creutzfeldt-Jakob disease).

Congenital disease or malformation

Following assisted reproduction using gametes from a heterologous donor, any congenital and/or genetic abnormality in a fetus or child which is classified as a major congenital malformation (Bonduelle et al., Human Reproduction 17, 671-694).

Please give details of the disease or abnormality of the fetus/child in section 6 (“consequence/reaction”).

Loss of cells or tissue(s)

Loss of (part of the) cells or tissue(s) during procurement, testing, processing, storage, distribution or transplantation.

Failure to engraft or insufficient growth

  • If the growth of cultured cells intended for transplantation is beneath expectation or requirement and in consequence transplantation cannot take place.
  • If the graft or transplanted material does not show the expected growth or increase in number of cells (e.g. reduced engraftment after hematopoietic stem cell transplantation).Specify in section 6 (“consequence/reaction”) whether the recipient had to undergo an additional procedure.

Incorrect product transplanted

  • If a different type of graft is used from that intended or requested.
  • If a graft is transplanted which had been selected and issued for a different recipient.
  • If a graft is transplanted which did not meet all the requirements for an appropriate product for the patient.

Near miss

Any mix-up or error which, if it had not been detected, could have led to transplantation of an incorrect product or the wrong recipient.

Other incident

Incidents in the tissue and transplantation chain which do not fit in the above categories.

Administrative error

  • If a mistake has been made in filling in or entering data (wrong letter / wrong number / wrong option selected).
  • If personal identifiers, medical or product data have been entered in the database / computer system of the hospital, tissue establishment which are not those of the intended recipient, donor, product or material.
  • If two or more records exist for a single recipient or donor in the database of the tissue establishment, hospital and/or laboratory.

Error in assessment or judgement

Any case of erroneous assessment of characteristics of a product or failure to respond appropriately to a test result, information on a form or other information about the recipient, donor or product.

Storage error

  • Any case where a product was not transported or stored under appropriate conditions between procurement and its transplantation in the tissue establishment, the hospital and/or laboratory.
  • If the maximum permitted time between collecting an issued product and the time of starting transplantation has been exceeded, leading to the product not being used.

Processing error

Any case of error in procuring or processing a product according to protocol in hospital or clinic, tissue establishment or laboratory. A freezing procedure is classified under processing.

Communication error

  • If important (medical) information is missing on a form used in procurement, testing, processing, requesting/ordering or transplantanting the product.
  • If incorrect (medical) details have been recorded on a form used in procurement, screening, processing, requesting/ordering or transplantation and this did not result from an error.
  • If no or unclear arrangements have been made between staff members about the performance of a certain task.

Identification error

  • If the identifiers on the accompanying form and/or product are not those of the donor from whom the tissue/cells have been procured or collected.
  • If a product has been requested for a different person from the intended recipient.
  • If the issued product is not the product which has been requested and selected for the recipient.
  • If the product which is in the vicinity of the recipient is not the product which has been issued for that person.
  • If the product is applied/transplanted in a person who is not the intended recipient for whom it has been selected and issued.

Product error

  • If the specifications of the product are different from the information given on the label.
  • If the product is faulty.
  • If the product is (possibly) infected.
  • If it is later discovered that at the time of procurement there was a reason why the donor should have not have been accepted for donation (e.g. the definitive autopsy findings report a hematological malignancy which was not known at the time of donation).
  • If a hererologous gamete donor is found be a carrier of a genetic abnormality.

Selection error

Any case where the product which is selected for a recipient does not meet all the specifications for an appropriate product for that recipient.

Technical error

Any case where technical apparatus or material for procuring, testing, processing, storage, transporting or transplanting a product was malfunctional or faulty.

Traceability failure

Any case where the chain from procurement to transplantation or destruction of cells or tissues has not been reliably documented.

Transplantation error

Any case where a transplantation has not been performed according to protocol or professional standard.

Error in test performance

An error in performance of a test on the donor, recipient or tissue/cell product.


Any deviation or error which does not fit into one of the above types.