Events

Field Safety Notices about BeneFusion VP1 and BeneFusion VP3

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 Shenzhen Shenke Medical Instrument Technical Development Co., Ltd. .

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 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
    Shenke medical has identified a potential problem with the benefusion infusion pump (benefusion vp1 in benefusion vp3) in the plastic screw connection used to secure the pump housing as it may break under certain conditions. in the internal test wear and tear has shown that broken plastic screw joints in red can support abnormal infusion flow management. in different cases, the dose of the infusion can be checked.

Device

BeneFusion VP1 and BeneFusion VP3

Manufacturer

Shenzhen Shenke Medical Instrument Technical Development Co., Ltd.
  • Source
    AMPMDRS