Events

Field Safety Notices about Baxter Coiled Tube Infusors

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Baxter.

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
    Field Safety Notice
  • Event Number
    SN2014(19)
  • Date
    2014-04-24
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    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 / Alerts
    "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."
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
  • Product Description
    Baxter Coiled Tube Infusors. Priority 2 – Warning
  • Manufacturer
    Baxter

Manufacturer

Baxter