Events

Field Safety Notices about Terumo Extracorporeal Tubing Sets involving the LN130B Over-pressure Safety Valve or the LH130 Single, Sterile Over-pressure Safety Valve

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 Terumo Cardiovascular Systems.

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.

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Type of Event
Field Safety Notice
Date
2017-07-17
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
This field safety notice calls attention to a situation that may arise with the ln130b over-pressure safety valve (ops valve) within your terumo extracorporeal tubing set or the lh130 single, sterile ops valve, and recommends how to check to ensure the duckbill valve within the ops valve is patent and allows flow through the valve. the ln130b or lh130 ops valves are to prevent reversal of blood flow and the prevention of air embolism as well as limit excessive negative and positive pressure in the vent catheter. the ops valve allows for flow in only one direction (from the catheter in the heart to the cardiotomy reservoir). .

Device

Terumo Extracorporeal Tubing Sets involving the LN130B Over-pressure Safety Valve or the LH130 S...

Model / Serial
Manufacturer
Terumo Cardiovascular Systems

Manufacturer

Terumo Cardiovascular Systems

Manufacturer Parent Company (2017)
Terumo Corp.
Source
AMPMDRS

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