Plum A+ infusion pumps 를 위한 안전성 경고 / 현장 안전성 서한

Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.

Risk of delay or interruption to treatment.The audible alarm on all listed Plum A+ infusion pumps may fail.The visual alarm is not affected. However, if the user does not notice the visual alarm they may be unaware of an interruption to the infusion eg air-in-line or occlusion.Improper mounting of components, poor soldering, and breakage of internal wiring connections may lead to failure of the audible alarm.The manufacturer’s FSN (905Kb) advises users to test the audible alarm before each use of the pump as an interim measure. However, these tests will not predict if the audible alarm will fail and will only indicate if it has already failed. It is possible for the audible alarm to fail in use, even after the test has been performed.Hospira is modifying the design of the audible alarm to resolve this problem. Once this has been completed, Hospira will contact users to arrange for replacement.