Events

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

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Maquet Australia Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2016-RN-01514-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2016-11-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01514-1
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 원인
    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.
  • 조치
    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...
  • 모델명 / 제조번호(시리얼번호)
    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