Adverse Occurrence type:
Never reported before this severe
Time to detection:
Alerting signals, symptoms, evidence of occurrence:
Hypotension, low O2 saturation. After 12 hours high fever. After 24 hours IC treatment. The five year old patient died 2 months after tx due to multiorgan failure, bleedings and encephalitis.
Demonstration of imputability or root cause:
Blood culture of patient positive: A. hemolytic streptococcus (product culture negative). The transplant's erytrocytes volume and number were normal.
TRIP annual report 2012 Biovigilance