Events

PLUM LifeCare 5000 Series and PLUM XL Familiy of Infusers 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-2013-RN-01288-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-12-10
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01288-1
  • 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
    The door roller assembly on the plum a lifecare 5000 series and plum xl has the potential to break which can lead to possible unrestricted flow and/or over delivery during the removal of the iv administration set's cassette from the pump.
  • 조치
    Hospira is requesting hospitals to take the following steps to inspect the door assemble prior to loading the cassette: -Open the cassette door by pulling on the lever - Unlatch the cassette door by pushing on the door release tab and pulling the door down. -Visually inspect the door roller pin for any evidence of the damage or door roller misalignment. -Ensure that the door roller spins smoothly with a finger touch. If any door rollers or pins appear losse, broken or missing, Hospira is advising to remove the device from use. Hospira is in the process of retiring the Plum LifeCare 5000 and Plum XL in 2015.

Device

PLUM LifeCare 5000 Series and PLUM XL Familiy of Infusers
  • 모델명 / 제조번호(시리얼번호)
    PLUM LifeCare 5000 Series and PLUM XL Familiy of Infusers Plum LifeCare 5000List Number: 02507Plum XLList Number: 11555Plum XLMList Number: 11846Plum XLDList Number: 11859ARTG Number: 138109
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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