Events

Alerte Ou Avis De Sécurité sur All T34 ambulatory syringe pumps need a sponge pad fitted to the battery compartment to prevent battery connection issues (MDA/2019/013)

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Caesarea Medical Electronics.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • Date
    2019-03-04
  • Date de publication de l'événement
    2019-03-04
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    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 / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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
  • Adresse du fabricant
    CME Medical UK (UK Distributor), a Becton Dickinson acquired company Mr Michael GarfittCustomer service line: 01253 206700customersupport@cmemedical.co.uk
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    MHRA