Events

Field Safety Notices about Cell Saver® Elite® disposable processing kits

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Haemonetics S.A..

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
  • Date
    2016-04-18
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    For some of the bowls that are used in these sets, the outer diameter at the base of the bowl causes issues with fitting the bowls into the chuck of the centrifuge. if the bowl does not fit into the centrifuge, it cannot be used and the kit needs to be replaced. if the bowl needs to be forced into the centrifuge by the operator, the bowl will still not be properly engaged, causing potential issues with bowl noise, bowls jumping from the centrifuge, and in some cases, broken bowls.

Device

Cell Saver® Elite® disposable processing kits

Manufacturer

Haemonetics S.A.