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 december 2014 maquet cardiopulmonary notified you via dyr 91 (fsn 2014-12-11) of the increased incidence of blood leakage from the gas outlet connector of the quadrox-id adult and small adult products including the hls and pls sets that contain related oxygenators of this product family. the increased leakage was due to a separation of a small number of the internal fibers from the polyurethane casting in the oxygenator. this separation resulted in the blood leakage that was the subject of the field safety notice. since the release of this notification we have been able to confirm the possible root cause that was described in the notification. additionally we have implemented and validated the necessary corrections that return the products to their original performance specifications. the correction necessary was the implementation of additional process controls during the production process of these fibers at our raw material supplier. the fibers produced under these increased process controls have now been delivered to maquet cardiopulmonary and used on the production of the finished oxygenator products.