Sorin Group, the manufacturers of the heater-cooler device linked to four patient deaths at WellSpan York Hospital in Pennsylvania, requested confirmation that its customers received a letter in July 2014 that warned of the infection risk posed by the device, according to The York Dispatch. The hospital is unable to confirm whether it ever received the warning notification, a WellSpan representative wrote in a statement.
The hospital reports having received an update containing information about potential problems with the heater-cooler machine through a third party notification system in August 2014, according the The York Dispatch. In this instance Sorin may have requested this confirmation to reduce liability associated with the device.
WellSpan's legal obligation to properly maintain and clean devices is not absolutely contingent on when it may have received notification of a problem from the manufacturer, a legal expert told The York Dispatch. Brett Marcy, spokesperson for WellSpan, said the hospital profoundly regrets any distress this confusion has caused and is deeply committed ensuring that all stakeholders receive the correct information, The York Dispatch reported.
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