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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
A 59-year-old man developed anaphylaxis following the application of chlorhexidine as an antiseptic.
The man had diabetes mellitus, sickle cell trait and non-ischaemic dilated cardiomyopathy. He, presented to a hospital for the elective implantation of HeartMate II left ventricular assist device (LVAD). A night prior to the scheduled LVAD implantation, he developed a mild skin rash and pruritus after the topical application of 2% chlorhexidine [chlorhexidine-gluconate] cloth wipes on his anterior chest. In the operating room, anaesthesia was induced with midazolam, sufentanil and vecuronium, and he was intubated endotracheally. His neck was prepared with a small concentration of antiseptic chlorhexidine. A central venous catheter was inserted and various antibiotics were...