Chemotherapy errors - medical device regulation

There are now two versions of the story:
a] Only one type of pump capable of being programmed for hourly or daily delivery rates. The mistake was in the programming.
b] Two similar looking pumps - one for hourly delivery and the other for daily delivery. The mistake was in the wrong pump being used.

I really have no way of establishing which of these stories are true. We'll wait for the BOI to release their findings....if they ever. But in both of these scenarios, the design of the pump is also important in minimizing the risks of operator error.

By the way, these pumps are actually regulated by the HSA as 'medical devices'. I wonder if they these design problems into consideration when they approve these pumps? Or just look at the brochures?