Events

Safety Alert for Heater Cooler Device

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

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
    2014-08-07
  • Event Date Posted
    2014-08-07
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140807b.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: sorin heater cooler device medical device manufacturer, sorin, has issued a field safety notice (fsn) concerning its heater cooler device. during the investigation work on some cardiac surgery patients infected with a slow growing mycobacterium chimaera, it has been identified that some hospitals’ heater cooler devices are contaminated. the manufacturer advises users that they can continue to safely use the heater cooler devices in accordance with the operator’s manual. it also recommends users of the followings: review information in fsn to assure that users are aware of proper water management in cardiac surgery theatre. specifically, assure that users understand mycobacteria and the potential contamination risks for cardiac surgeries as mentioned in the fsn. review heater cooler operating practices and cardiac surgery theatre water management practices. also evaluate heater cooler device(s) for potential contamination. refer to the heater cooler device operator’s manual and/or information in fsn, and review the necessary disinfection practices to assure practices are aligned with the directions. if users are concerned that vigilance to the operating instructions may be in question, perform microbiological sampling of the water in heater cooler device, disinfect the device and determine if decontamination is necessary. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 7 aug 2014.

Device

Heater Cooler Device
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Sorin Heater Cooler Device
  • Manufacturer
    Sorin

Manufacturer

Sorin