Events

Hospira Plum 360 Infusion System 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Hospira Pty Limited 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-2017-RN-00729-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-06-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00729-1
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • 데이터 추가 비고
  • 원인
    Icu medical has identified a potential for the connectivity engine (ce) module to disengage from the main chassis. in a rare situation, this could lead the plum 360 infuser to power down without an alarm notification resulting in a delay of either initiation of a therapy or interruption of an active infusion. in rare circumstances, these conditions could lead to serious adverse health consequences related to life threatening or permanent injury, which may include death.To date, icu medical has not received any reports of serious injury or death associated with this issue.
  • 조치
    ICU Medical will be contacting users and arranging for inspection of all affected Plum 360 infusers. The chassis will be replaced as required. In the interim, ICU Medical is advising users to inspect the affected Plum 360 Infusers using the instructions provided in the customer letter in order to verify that the infuser is working. If at the end of testing a loose CE module or blank display is observed, the infuser is to be removed from service, and the user is to record the S/N and contact the ICU Service Department. Otherwise, the infuser can be returned to clinical use. If the Plum 360 Infuser powers down without an alarm notification during infusion, use another Plum 360 Infuser for infusion or consider use of alternative infusion methods based on the clinical situation.

Device

Hospira Plum 360 Infusion System

Manufacturer

Hospira Pty Limited
  • 제조사 모회사 (2017)
    Pfizer
  • Source
    DHTGA