Events

Safety Alert for MARS Kit Gambro, Type 1116/1-X-MARS

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

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
    2018-01-03
  • Event Date Posted
    2018-01-03
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180103a.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: baxter healthcare mars kit gambro, type 1116/1-x-mars medical device manufacturer, baxter healthcare, has issued a medical device safety alert concerning its mars kit gambro, type 1116/1-x-mars [product code: 800540; lot numbers (expiration date): 22651 (01 september 2019), 22708 (30 september 2019)]. the manufacturer has received customer complaints regarding leakage in the albumin circuit. the leakage was caused by an inadequate adhesive connection of the tubing to the hansen connector of the mars tube set which is part of the mars treatment kit. according to the manufacturer, an undetected leaking albumin circuit could lead to excessive fluid removal from the patient during albumin dialysis. this could lead to hypovolemia. delay or interruption of therapy may also occur if the issue is detected during priming. the manufacturer has not received any reports of adverse events or patient injury associated with this issue. affected users are advised to locate and remove all affected product from facility. product recall is on-going. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 03 january 2018.

Device

MARS Kit Gambro, Type 1116/1-X-MARS
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Baxter Healthcare MARS Kit Gambro, Type 1116/1-X-MARS
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare