Clinical symptoms or situations suggesting that any of the following reactions might have occurred in an MPHO recipient (Notify Library’s adverse occurrence type description in brackets) should be seen as triggers for a notification. It should be noted that the list is not exhaustive.
8.3 TRIGGERS FOR A NOTIFICATION OF SUSPECTED HARM TO A RECIPIENT
- Unexpected* primary infections possibly transferred from the donor to recipient (e.g. viral, bacterial, parasitic, fungal, prion) (Harm to a Recipient - Infection);
- Transmitted infection (viral, bacterial, parasitic, fungal, prion) possibly due to contamination or cross-contamination by an infectious agent on the procured tissues or associated materials from procurement to clinical application (Harm to a Recipient - Infection);
- Hypersensitivity reactions, including allergy, anaphylactic reactions or anaphylaxis (Harm to a Recipient - Immunological complications - Allergic Reaction);
- Malignant disease possibly transferred by the MPHO (whatever the origin, donor or process) (Harm to a Recipient - Malignancy);
- Unexpectedly delayed or absent engraftment, graft failure (including mechanical failure) (Harm to a Recipient - Miscellaneous complications - Graft failure);
- Toxic effects from MPHO or associated materials (Harm to a Recipient - Miscellaneous complications - Toxicity);
- Unexpected immunological reactions due to mismatch, e.g. ABO, HLA Rh, etc. (Harm to a Recipient - Immunological complications - Detrimental immunization)
- Aborted procedures involving unnecessary exposure to risk e.g. wrong MPHO supplied, discovered after patient is anaesthetised and the surgical procedure has begun (Harm to a Recipient - Miscellaneous complications - Undue exposure to risk-intervention)
- Suspected transmission of genetic disease (Harm to a Foetus or Offspring - Genetic)
- Suspected transmission of other (non-infectious) illness (Harm to a Recipient - Non infectious, Non malignant transmissions)
* In certain circumstances, clinicians may knowingly transplant an MPHO from a seropositive donor (e.g. bone marrow transplantation from a CMV seropositive donor to a CMV seronegative recipient).