Events

Recall of AQUARIUS Regional Citrate Anticoagulation (RCA) Hemofiltration Device

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by AA-Med 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-2015-RN-00118-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-02-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00118-1
  • 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
    Edwards lifesciences (previous legal manufacturer of aquarius devices in the market) initiated a fsca to address the issue related to the potential risk of fluid overload or fluid loss caused by the repetitive clearing of the balance alarm without solving the balance alarm cause. field safety notices were sent to customers warning users about the potential danger for repetitive clearing of the balance alarm without solving the balance alarm cause.Nikkiso europe (manufacturer of aquarius devices) has now completed a software solution to prevent the repeated overriding of the balance alarm by implementing total fluid loss (tfl) management in software 6.02. this product improvement is accompanied by a revised instructions for use (ifu).
  • Action
    Nikkiso Account Manager will contact the customer shortly to schedule the onsite modification, calibration and training based on availability of the hospital staff as well as devices.

Device

AQUARIUS Regional Citrate Anticoagulation (RCA) Hemofiltration Device
  • Model / Serial
    AQUARIUS Regional Citrate Anticoagulation (RCA) Hemofiltration DeviceProduct Codes: GEF09500, All Citrate Platform 6 Devices ARTG Number:189947
  • Manufacturer
    AA-Med Pty Ltd

Manufacturer

AA-Med Pty Ltd
  • Source
    DHTGA