Events

Avis De Sécurité sur Baxter Coiled Tube Infusors

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland qui a été fabriqué par Baxter.

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
    Field Safety Notice
  • Numéro de l'événement
    SN2014(19)
  • Date
    2014-04-24
  • Pays de l'événement
    Ireland
  • Source de l'événement
    HPRA
  • URL de la source de l'événement
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/baxter-coiled-tube-infusors.-priority-2-warning&id=38d0f925-9782-6eee-9b55-ff00008c97d0
  • Notes / Alertes
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • Notes supplémentaires dans les données
  • Cause
    Following a review of customer complaints for over-infusion, baxter has identified an error in the directions for use for the coiled tube infusor system. as outlined in the attached fsn, direction for use #5 is incorrect for the coiled tube infusor. the nominal (labelled) flow rate is achieved when the elastomeric reservoir is positioned 6-8 inches (15-20cm) below the distal luer lock and not when positioned at the same height as stated in the directions for use.  baxter has indicated that the following products which have been supplied to the irish market are impacted by this issue.  product codes product name 2c1071kjp single day infusor 2 ml/h system 2c1073kjp half day infusor sv 5 ml/h system 2c1080kjp multiday infusor 0.5 ml/h system.
  • Action
    The IMB advise that users:  (1) Follow the instructions outlined by the manufacturer in the field safety notice (FSN) attached.  (2) Forward this IMB Safety Notice to all those within your organisation that need to be aware of this information. Please also pass this Safety Notice and the attached FSN on to any end users or organisations where these devices may have been distributed.

Device

Baxter Coiled Tube Infusors
  • Modèle / numéro de série
  • Description du dispositif
    Baxter Coiled Tube Infusors. Priority 2 – Warning
  • Manufacturer
    Baxter

Manufacturer

Baxter