Events

D-Vapor and D-Vapor 3000 Vaporisers (used in connection with Baxter Desflurane Agent and Bottles) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Draeger Medical 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-00432-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-04-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00432-1
  • 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
    Dräger has become aware of isolated cases in which the unwanted release of evaporating agent was observed by users at the end of the filling procedure. dräger has identified two potential root causes for the reported issues of unwanted release of evaporating agent after filling:a. non observance of the correct filling procedure, especially with regards to the 2 to 3 seconds pause before bottle removal after filling; andb. high friction of the drug bottle valve inside the vaporiser opening may delay closing of the bottle valve after fillingthe release of unintended evaporating agent may lead to spraying of aerosol into face and eyes of the operator. eye contact with volatile anaesthetics can result in serious irritation; immediate flushing of eyes and consultation of a physician is recommended.
  • 조치
    The sponsor is advising users to adhere to the product IFU when handling the device. Recently updated Material Safety Data Sheets (MSDS) of Desflurane manufacturers recommend the wearing of safety glasses when handling these substances. This action has beeen closed-out on 30/01/2017

Device

D-Vapor and D-Vapor 3000 Vaporisers (used in connection with Baxter Desflurane Agent and Bottles)
  • 모델명 / 제조번호(시리얼번호)
    D-Vapor and D-Vapor 3000 Vaporisers (used in connection with Baxter Desflurane Agent and Bottles)All Serial Numbers affectedARTG Number: 114688
  • Manufacturer
    Draeger Medical Australia Pty Ltd

Manufacturer

Draeger Medical Australia Pty Ltd