Adverse reactions reporting

According to CSA standards, hospitals are required to report to Canadian Blood Services adverse reactions following transfusion if they are thought to be caused by a deficiency of the blood product that affects the safety of the component and is attributable to a regulated activity at Canadian Blood Services (e.g., donor selection, collection, production). Hospitals also voluntarily report adverse reactions following transfusion through TTISS and/or as required to Health Canada, in cases where the reaction can be attributed to a regulated activity at the hospital that affected the safety of the blood component (e.g., pooling, washing, irradiation).

How to report adverse transfusion reactions

To facilitate reporting of adverse transfusion reactions, we have prepared A Guide to Reporting Adverse Transfusion Reactions, which includes links where reporting forms can be found.

Which adverse transfusion reactions are reported to Canadian Blood Services

The adverse transfusion reactions data reported to Canadian Blood Services are summarized in the graphs below. It is important to note that only adverse reactions related to the transfusion procedure are included in these graphs. Not included here are adverse reactions reported to Canadian Blood Services that are deemed to be not reportable to Health Canada (e.g., the reaction was minor or unrelated to the transfusion procedure).

Ongoing education with hospital health-care professionals promotes the appropriate reporting of transfusion reactions related to Canadian Blood Services’ products. Those efforts have led to a reduction in the number of adverse transfusion reactions reported to Canadian Blood Services that are related to the patient’s underlying condition (e.g., TACO or febrile reactions) rather than to the product.  

Adverse reaction reports received by Canadian Blood Services may be revised as additional information becomes available. Therefore, the numbers reported for a given year may be subject to change.

The adverse transfusion reactions data shared by Canadian Blood Services are meant to supplement rather than replace the official reporting that comes from the TTISS program.

 

Figure 1: Total reportable† adverse reactions reported to Canadian Blood Services

Reportable is defined as reportable to Health Canada by Canadian Blood Services, as determined by the Blood Regulations.

Figure 2: Reportable adverse reactions reported to Canadian Blood Services by category.

Note: The "Other" category includes transfusion adverse reactions  that were originally reported from Canadian Blood Services to Health Canada (namely suspected TRALIs), but following further investigation were reclassified as a reaction that is not reportable to Health Canada as per the Blood Regulations (due to underlying illness, TACO, etc.) (see Figure 3). (TRALI=transfusion-related acute lung injury) 

Figure 3:  Details of "Other" adverse reactions reported to Canadian Blood Services.

Note: The "Other" category includes transfusion adverse reactions that were originally reported from Canadian Blood Services to Health Canada, but following further investigation were reclassified as a reaction that is not reportable to Health Canada as per the Blood Regulations. Starting in 2016, Canadian Blood Services is no longer required to report acute hemolytic reactions, delayed hemolytic reactions and PTP (post-transfusion purpura), therefore these data may no longer be captured here. (TACO=transfusion-associated circulatory overload)

Figure 4:  Fatalities reported to Canadian Blood Services by category.

Note: The "Other" category includes transfusion adverse reactions that were originally reported from Canadian Blood Services to Health Canada, but following further investigation were reclassified as a reaction that is not reportable to Health Canada as per the Blood Regulations. . 2015: 2/2 fatalities are undetermined to be related to a transfusion event.

All data on adverse transfusion reactions reported to Canadian Blood Services, from 2103–2019, can be viewed in this data file.

Total adverse events reported to Canadian Blood Services

Adverse events reported to Canadian Blood Services by categories

"Other" category includes transfusion adverse events ultimately found to be related to the patient’s underlying condition and not due to the transfused blood component.

Details of "other" adverse events reported to Canadian Blood Services

"Other" category includes transfusion adverse events ultimately found to be related to the patient’s underlying condition and not due to the transfused blood component. Starting in 2016, Canadian Blood Services is no longer required to report acute hemolytic reactions, delayed hemolytic reactions and PTP, therefore these data may no longer be captured here.

Fatalities reported to Canadian Blood Services by category

"Other" category includes transfusion adverse events ultimately found to be related to the patient’s underlying condition and not due to the transfused blood component. 2015: 2/2 fatalities are undetermined to be related to a transfusion event. 2014: 1/4 fatalities is undetermined to be related to a transfusion event.