Events

NIO-A device (Automatic intraosseous infusion device that provides rapid, safe and easy intravascular access through the bone marrow) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Aero Healthcare 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-01138-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-09-16
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01138-1
  • 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
    During the operation of the nio-a, the needle was not released from the device as expected. the device was placed on the floor and after several minutes the needle was released spontaneously.As the device is intended to penetrate the bone into the marrow cavity, it is designed in such way that the needle is released intensely due to a compressed spring force. spontaneous release of the needle from the device may result in serious injury of the patient, caregiver or any of the surrounding people.This action was undertaken prior to consultation with the therapeutic goods administration (tga).
  • 조치
    Aero healthcare is advising users to return the affected units. This action has been closed-out on 26/05/2017.

Device

NIO-A device (Automatic intraosseous infusion device that provides rapid, safe and easy intravasc...
  • 모델명 / 제조번호(시리얼번호)
    NIO-A device (Automatic intraosseous infusion device that provides rapid, safe and easy intravascular access through the bone marrow)Lot Number: 160024ARTG Number: 145376
  • Manufacturer
    Aero Healthcare

Manufacturer

Aero Healthcare