Events

Field Safety Notices about Level 1® Normothermic IV fluid administration sets for use with the Level 1® fast flow fluid warmer units

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

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
    SN2011(05)
  • Date
    2011-04-08
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/level-1-normothermic-iv-fluid-administration-sets-for-use-with-the-level-1-fast-flow-fluid-warmer-units&id=f797f825-9782-6eee-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
    Smiths medical has become aware of an increased trend in reports of kinking of the tubing on certain level 1® normothermic iv fluid administration sets (models di-65hl, di-75 and di-150). in some cases, the kink may lead to a decrease in the flow of fluid to the patient. a reduction in flow rate may lead to a delay of therapy, which could result in patient injury.
  • Action
    The Irish Medicines Board advises users of this product to inspect their inventory and segregate the affected products for return to the manufacturer as per the attached field safety notice.  Users should exercise extreme caution when using the alternative replacement products and remain cognisant of the clinical risks associated with these sets, which are not equipped with the F-50 Gas Vent Filter Assembly.  Users should also take care to:  • Ensure that all Level 1® fast flow fluid warmer units contain a copy of the quick reference guide distributed by Smiths Medical in 2007.  • Contact the manufacturer to request a copy of the quick reference guide if required.

Device

Level 1® Normothermic IV fluid administration sets for use with the Level 1® fast flow fluid warm...
  • Model / Serial
  • Product Description
    Level 1® Normothermic IV fluid administration sets for use with the Level 1® fast flow fluid warmer units
  • Manufacturer
    Smiths Medical

Manufacturer

Smiths Medical