8.3 Triggers for a notification of suspected harm to a recipient

Clinical symptoms or situations suggesting that any of the following reactions might have occurred in an MPHO recipient (abbreviated descriptions in brackets) should be seen
as triggers for a notification. It should be noted that the list is not exhaustive.

a) Unexpected* primary infections possibly transferred from the donor to recipient (e.g. viral, bacterial, parasitic, fungal, prion) (Infection - Donor);
b) 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 (Infection – MPHO);
c) Hypersensitivity reactions, including allergy, anaphylactoid reactions or anaphylaxis (Hypersensitivity);
d) Malignant disease possibly transferred by the MPHO (whatever the origin, donor or process) (Malignancy);
e) Unexpectedly delayed or absent engraftment, graft failure (including mechanical failure) (Failure);
f) Toxic effects from MPHO or associated materials (Toxicity);
g) Unexpected immunological reactions due to MPHO mismatch (Mismatch)
h) Aborted procedures involving unnecessary exposure to risk e.g. wrong MPHO supplied, discovered after patient is anaesthetised and the surgical procedure has begun (Undue Risk)
i) Suspected transmission of genetic disease (Genetic transmission)
j) Suspected transmission of other (non-infectious) illness (Other Transmission)

* In certain circumstances, clinicians may knowingly transplant an infective donation (e.g. a CMV positive bone marrow donation).