Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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Since october 2010 smiths medical has received a total of 4 complaints regarding system errors that cause the medfusion 4000 pump to stop running. there have been no reports of patient injury or death. investigation has identified the root cause to be related to a software anomaly that originated during development that causes a particular history log corruption to occur. further under infrequent circumstances the normal error recovery mechanism for the history corruption (i.E. clear history) is not successful. when the recovery mechanism is not successful the "watchdog fail-safe" alarm is triggered. the combination of the corruption and unsuccessful recovery results in a persistent re-occurrence of the "watchdog fail-safe" on every power-up preventing further use of the pump.