Events

Field Safety Notices about H-1200 Fast Fluid Warmer with integrated Air Detector / Clamp and H-31B and H-30 Air Detector / Clamp Accessory

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
    SN2008(02)
  • Date
    2008-01-31
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/h-1200-fast-fluid-warmer-with-integrated-air-detector-clamp-and-h-31b-and-h-30-air-detector-clamp-accessory&id=0594f825-9782-6eee-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
    The risk of air embolism if the power of the fluid warmer unit is interrupted either manually or through power failure during an air detection event.
  • Action
    Further to this incident the Irish Medicines Board (IMB) advises users to discontinue the use of the device until further notice.   Identify and quarantine affected devices until further notice.   If no alternative fluid warmer is available, ensure users are aware of the advice provided in the manufacturer’s customer letter (copy attached as appendix 1) and ensure that the quick reference guide is attached to all affected devices.   Contact the manufacturer to request a copy of quick reference guide if not attached to all affected devices

Device

H-1200 Fast Fluid Warmer with integrated Air Detector / Clamp and H-31B and H-30 Air Detector / C...
  • Model / Serial
  • Product Description
    H-1200 Fast Fluid Warmer with integrated Air Detector / Clamp and H-31B and H-30 Air Detector / Clamp Accessory
  • Manufacturer
    Smiths Medical

Manufacturer

Smiths Medical