Events

Safety Alert Or Field Safety Notices for All T34 ambulatory syringe pumps need a sponge pad fitted to the battery compartment to prevent battery connection issues (MDA/2019/013)

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Caesarea Medical Electronics.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Date
    2019-03-04
  • Event Date Posted
    2019-03-04
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/all-t34-ambulatory-syringe-pumps-need-a-sponge-pad-fitted-to-the-battery-compartment-to-prevent-battery-connection-issues-mda-2019-013
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    Manufactured by caesarea medical electronics (cme) ltd, a bd company – instructions provided to reduce the risk of delay to therapy and loss of infusion if the battery loses connection.
  • Action
    BD/CME issued 2 versions of the Field Safety Notices (FSNs) with actions targeted to the type of healthcare provider. There is a combined version on MHRA’s website. Make sure you read the appropriate pages of the combined version of the FSN. In Scotland, the NDC Reference is Customer Alert Notice CAN336v5.

Device

All T34 ambulatory syringe pumps need a sponge pad fitted to the battery compartment to prevent b...

Manufacturer

Caesarea Medical Electronics
  • Manufacturer Address
    CME Medical UK (UK Distributor), a Becton Dickinson acquired company Mr Michael GarfittCustomer service line: 01253 206700customersupport@cmemedical.co.uk
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    MHRA