Other, other text: on review of the reported event and device, the pre-investigation hazard code was updated for a pca pump.The reportability decision has changed to non-reportable.The event does not meet the definition of a reportable death or serious injury as the malfunction of the device did not cause or contribute to a patient death, a life-threatening event, permanent impairment of a body function or structure, required medical or surgical intervention to preclude serious impairment of a body structure or function.Additionally, the product family hazard analysis indicates that the device in the reported incident would not likely cause or contribute to a death or serious injury if the malfunction were to recur.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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