Events

Hospira LifeCare 4200 Patient-Controlled Analgesia (PCA) Infuser, PCA with MedNet Software Infusers (general purpose infusion pump).4200 PCA Infuser; List Number 610F78201PCA and PCA with MedNet Software Infusers; List Number: 612070901 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-2012-RN-00936-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2012-09-28
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00936-1
  • 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
    Hospira has received reports overseas from customers related to the improper use of the slide clamp when the syringe (vial) was manipulated or when stopping infusion during delivery of fluids. users are being informed of the correct usage of the slide clamp and/or syringe manipulation to prevent over delivery.
  • 조치
    Customers are being advised of the correct use of the c slide clamp and/or syringe manipulation to prevent over delivery.

Device

Hospira LifeCare 4200 Patient-Controlled Analgesia (PCA) Infuser, PCA with MedNet Software Infuse...
  • 모델명 / 제조번호(시리얼번호)
    Hospira LifeCare 4200 Patient-Controlled Analgesia (PCA) Infuser, PCA with MedNet Software Infusers (general purpose infusion pump).4200 PCA Infuser; List Number 610F78201PCA and PCA with MedNet Software Infusers; List Number: 612070901ARTG Number: 138109
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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