Events

Recall of ME DPHC 0001 deltastream HC, 230V (Cardiopulmonary bypass system heating/cooling unit)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Lovell Surgical Supplies International Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2016-RN-00362-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-04-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00362-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    There have been reported cases of nontuberculous endocarditis caused by mycobacteria or infections after cardiac surgery, in which hypothermia or hyperthermia devices were used. the manufacturer is updating the cleaning procedure of the device as a precautionary measure. updated ifus are expected to be available by the end of june 2016.
  • Action
    The manufacturer is advising users to follow the following updated cleaning procedures: · Clean the device every 14 days with Sanosil solution (3% H202). Since there may be an excess pressure during the cleaning process the tank lid must remain open during the cleaning process Furthermore, it is recommended that the water is changed daily and after each patient. · Change least once a year, the hose assembly. · All relevant hypothermia and hyperthermia devices should be operated in a separate room from the operating theatre. If this is not possible, another suitable measure should be found to ensure the risk of infection is effectively minimised. For example, by increasing the disinfection frequency of the surfaces of the devices and changing gloves after cleaning the equipment. · Perform regular checks for contamination of equipment. The manufacturer recommends monthly intervals to determine the quality of the water.

Device

ME DPHC 0001 deltastream HC, 230V (Cardiopulmonary bypass system heating/cooling unit)

Manufacturer

Lovell Surgical Supplies International Pty Ltd