Events

Alerte Ou Avis De Sécurité sur Plum 360 infusion pumps

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 ICU Medical.

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
    2018-02-15
  • Date de publication de l'événement
    2018-02-15
  • 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/plum-360-infusion-pumps-user-actions-required-to-prevent-risk-of-interrupted-infusion-or-delay-to-treatment
  • 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
  • Cause
    Manufactured by icu medical (formerly hospira) – potential for connectivity engine module to disengage from main chassis, which may lead to power down without an alarm (mda/2018/006).
  • Action
    Identify affected pumps, which were manufactured from 29 April 2015 to 25 October 2016 inclusive – see the spreadsheet listing device serial numbers which accompanies this Medical Device Alert and the manufacturer’s Field Safety Notice (FSN). If you are still unsure, contact the manufacturer. Inspect affected pumps as detailed in the FSN. If a loose connectivity engine module or blank display is found, remove the pump immediately from service, and contact manufacturer for repair. If the pump powers down without an alarm, use an alternative pump, and contact manufacturer for repair. Assist manufacturer to schedule appointments for inspection/repair and ensure pumps are made available to manufacturer for inspection/repair at the scheduled time/date. Ensure you have read the Field Safety Notice and have completed and returned the acknowledgement form as currently the manufacturer has not received sufficient responses

Device

Plum 360 infusion pumps
  • Modèle / numéro de série
  • Description du dispositif
    The manufacturer provided a customised list of serial numbers with the FSN in June 2017. To identify affected devices either refer to the customised list, or review the attached spreadsheet below.
  • Manufacturer
    ICU Medical

Manufacturer

ICU Medical
  • Adresse du fabricant
    ICU Medical Customer Service Tel: 020 3357 9400
  • Société-mère du fabricant (2017)
    Pfizer
  • Source
    MHRA