Events

Safety Alert for sleep safe sets

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Fresenius Medical Care.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-12-03
  • Event Date Posted
    2013-12-03
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131203.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: fresenius medical care sleep safe sets the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) issued a medical device safety alert concerning sleep safe sets manufactured by fresenius medical care. the affected article numbers are 5016921 sleep safe set, 5016931 sleep safe set plus, 5017391 sleep safe set paed, and 5017491 sleep safe set plus (japanese version). furthermore, the affected batch numbers of 5016931 sleep safe set plus are ugs231, uis031, uis032, and uks091. during the continuous monitoring of the sleep safe tubing systems on the market, the manufacturer has become aware of possible leakages caused from a small hole at the patient connector which might not be detected by visual inspection. the sleep safe cycler cannot detect such a leakage. therefore, there is a potential risk of infection for the patient, e.G. the development of peritonitis. so far, no case of peritonitis has been observed due to such a leakage. the manufacturer recommends users to stop using the affected product batches and they will organize the replacement of the affected sleep safe sets. according to the local supplier, the affected products were not distributed in hong kong. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con341232 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 3 december 2013.

Device

sleep safe sets
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Fresenius Medical Care sleep safe sets
  • Manufacturer
    Fresenius Medical Care

Manufacturer

Fresenius Medical Care