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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In very rare cases it is possible for a hl 20 twin pump module (tpm) to unintentionally increase its speed for a 1.5 - 2 second period of time before returning to its originally set speed. this malfunction can only occur when the tpm is used for cardioplegia and set up in a master/ slave configuration. during the malfunction a very transient incorrect mixing of the cardioplegia solution can occur before the pump speed returns to its original setting. this behavior can only occur when one of the tpm pumps is set as cardioplegia slave and the as cardioplegia master pump. when the tmp is used in any other confirguation this malfunction does not occur.