Events

Alerte Ou Avis De Sécurité sur Suction canisters and liners, Receptal system

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 Hospira (formerly manufactured by Abbott).

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
  • ID de l'événement
    MDA/2013/026
  • Numéro de l'événement
    CON270677
  • Date
    2013-05-01
  • Date de publication de l'événement
    2013-05-01
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON270677?tabName=allTabs
  • 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
    Potential failure or loss of suction. due to a number of customer complaints, hospira has issued a field safety notice (dated 12 april 2013) to recall all 1 litre devices and instruct customers to seek alternatives. the mhra is not confident that hospira has sufficient alternative stock available to supply the demand during a recall. the vacuum needed to create the suction cannot be created if the hard canister and the single-use liner are not properly seated during use, or if the liner separates from the canister during use. hospira has not yet identified the root cause of this failure. an investigation is ongoing. hospira cannot guarantee that the pre-use checks (listed below) will identify all defective units. therefore, a unit could pass the pre-use checks and still fail during use.
  • Action
    Identify affected devices. Ensure that users are aware of the manufacturer’s Field Safety Notice. Seek alternative devices immediately and return affected devices to the manufacturer. Until alternative devices are available: Perform pre-use checks (see below).  If defective units are identified, remove from use. Exercise caution in use as failure can occur despite the pre-use checks. Ensure that a back-up suction device is available at all times. Until alternatives are made available, the following pre-use checks should be carried out: During assembly, check the underside of the liner lid to ensure that the liner is not misaligned and there is a flush connection. Verify that the correct vacuum pressure can be achieved and that there is no loss of suction.

Device

Suction canisters and liners, Receptal system
  • Modèle / numéro de série
  • Description du dispositif
    Suction canisters and liners. All Receptal: 1 litre canisters (List number 43449), 1 litre PVC liners (List number OL212) and 1 litre PE liners (List number OL213). All batch numbers are affected. The Receptal system is a closed, disposable suction system that is used to isolate suction waste. It is used with adult, paediatric and neonatal patients.
  • Manufacturer
    Hospira (formerly manufactured by Abbott)

Manufacturer

Hospira (formerly manufactured by Abbott)
  • Société-mère du fabricant (2017)
    Pfizer
  • Source
    MHRA