Alerta De Seguridad O Notificaciones De Seguridad para All T34 ambulatory syringe pumps need a sponge pad fitted to the battery compartment to prevent battery connection issues (MDA/2019/013)

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 battery that was originally validated for use in the T34 pump was the Duracell (MN1604) 6LR61 9v battery.There is a +/- 2mm tolerance in size, which is allowed within IEC Standards. However, this could result in the battery moving within its housing, leading to a possible loss of connection. In some circumstances, this may result in the pump shutting down.CME are now rolling out a corrective action to fit sponge pads within the battery compartment of the syringe pumps, in order to improve battery connectivity.