KIMVENT Closed Suction Systems (Tube, tracheal, general-purpose, single-use) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Kimberly Clark Aust 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-2015-RN-00827-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-09-04
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    There is a potential that the thumb valve of a very small percentage of kimvent closed suction systems can remain partially open after suctioning was completed, even though the valve appeared to be closed or in the “locked” position. this situation can result in a partial air leak from the ventilator circuit triggering the ventilator alarm and replacement of the closed-suction device.
  • 조치
    Halyard Health is providing work around instructions to assist end users correct valve leaks caused by this issue. Halyard Health is undertaking an investigation to prevent this issue from occurring. This action has been closed-out on 18/08/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    KIMVENT Closed Suction Systems (Tube, tracheal, general-purpose, single-use)KimVent Closed Suction System - Neonates/Paediatrics, 5F, 6F and 8F Y Adpater5F Lot #: M5067T05 & M5076T4026F Lot #: M5054T5128F Lot #: M5089T503 & M5082T502KimVent Closed Suction System - Adults, 14F, DSELot #: M5085T604KimVent Turbo-Cleaning Closed Suction System - Adults, 12F, DSE Lot #: M5096T306KimVent Turbo-Cleaning Closed Suction System - Adults, 14F, DSELot #: M5080T301ARTG: 129684
  • Manufacturer

Manufacturer