All T34 ambulatory syringe 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.

The manufacturer has identified that there can be a +/- 2mm overall size difference between battery brands used with CME’s T34 ambulatory syringe pumps.This could result in battery movement within the battery housing leading to a possible loss of connection. This may result in the pump shutting down.Be aware that if the pump’s battery connectors and/or housing are inadvertently damaged during these checks, and the pump is outside of the warranty period, the manufacturer may charge for pump repair/replacement.