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
    2016-12-21
  • Event Date Posted
    2016-12-21
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20161221a.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) of the united kingdom has posted a medical device safety alert concerning sleep-safe sets [article numbers: 5016921, 5016931, 5017391, 5017491 and f00005377], manufactured by fresenius medical care. during the continuous monitoring of the sleep safe tubing systems on the market, the manufacturer has become aware of an increased number of leakages caused by overwelded coils on the patient and the drainage line. overwelded coils could lead to difficulties in unrolling the patient and drainage line and thus leakages may occur. these possible damages might not be visually detected. the sleep safe and sleep safe harmony cycler cannot detect such a leakage. therefore, there is a potential risk of infection for the patient, particularly the development of peritonitis. until a complete replacement of potentially affected batches is possible, affected users are instructed to take the following handling instructions:- unroll carefully the tube coils of the sleep safe sets; if unrolling is not possible, discard the sets; if unrolling is successful, check carefully the patient line for leakages during priming. the manufacturer will arrange replacement of the affected sleep safe sets. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notices-12-december-16-december-2016 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 21 december 2016.

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