Events

Recall of MAQUET HLS and PLS Sets with BIOLINE Coating (extracorporeal support sets)BE-HLS 5050 HLS Set Advanced 5.0

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Maquet Australia 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-01514-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-11-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01514-1
  • 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
    In january 2015 maquet cardiopulmonary noticed an increase in the frequency of complaints for the hls and pls sets regarding blood leaking from the gas outlet connector. in the defective products between 6-14 fibers have separated from the polyurethane casting (or 'potting'), which is at the ends of the fibers. this separation allows patient blood to leak out of the system (via the gas outlet connector). a safety alert was issued to alert customers regarding this issue at the time.Since the release of safety alert, maquet has identified the root cause and have implemented and validated the necessary corrections that return the products to their original performance specifications. due to the risks associated with the use of the oxygenators with increased leakage, maquet is now initiating a recall of the potentially affected lot numbers.
  • Action
    Customers are advised to quarantine affected products in their inventory and return them to Maquet. A credit will be issued upon receipt of the returned products.

Device

MAQUET HLS and PLS Sets with BIOLINE Coating (extracorporeal support sets)BE-HLS 5050 HLS Set Adv...
  • Model / Serial
    MAQUET HLS and PLS Sets with BIOLINE Coating (extracorporeal support sets)BE-HLS 5050 HLS Set Advanced 5.0 Product Order Number: 70104.8127All Lot Numbers below 70104520BE-HLS 7050 HLS Set Advanced 7.0 Product Order Number: 70104.7753All Lot Numbers below 70100115BE-PLS 2050 PLS SetProduct Order Number: 70102.7818All Lot Numbers below 70104119BE-PLS 2051 PLS Set PlusProduct Order Number: 70105.0310All Lot Numbers below 70102843ARTG Numbers: 193475, 192105
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    DHTGA