Events

Safety Alert for Prismaflex Control Unit

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
    2017-02-23
  • Event Date Posted
    2017-02-23
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170223.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 prismaflex control unit medical device manufacturer, baxter healthcare, has issued a medical device safety alert concerning its prismaflex control unit, details product models, serial numbers and software versions as below: product models: 1) prismaflex system; 2) prismaflex 4.11; 3) prismaflex 5.00 row; 4) prismaflex 6.10 row; 5) prismaflex 7.Xx row serial numbers: all software versions: 1) 4.10, 6.1 0, 7.10 & 7.11; 2) 4.10, 6.10, 7.10 & 7.11; 3) 6.10 & 7.10; 4) 6.10 , 7.10 & 7.11; 5) 6.10 , 7.10 & 7.11 the manufacturer has received reports of device operators failing to adhere to the instructions for use pertaining to the safe unloading of disposable sets from the prismaflex control unit. these steps are required to safely disconnect the patient before proceeding to unload the filter set after treatment. if not followed, severe blood loss may occur with a potentially fatal outcome. according to the manufacturer, unloading of the disposable set without following the instructions and warnings on the prismaflex control units may lead to severe blood loss and potentially fatal outcomes. according to the local supplier, there were no adverse events and complaints reported in hong kong that potentially related to this issue. the manufacturer advises that operators may continue to safely use the affected units by following the instructions provided in the prismaflex operator’ s manual and the on-screen instructions when unloading the disposable set. specifically, operators should ensure that all lines are clamped and the patient is disconnected before proceeding with unloading. the manufacturer will be releasing an updated software version that will take additional measures to further ensure patient safety. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 23 february 2017.

Device

Prismaflex Control Unit
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Baxter Healthcare Prismaflex Control Unit
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare