Events

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-01335-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-10-25
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01335-1
  • 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
    Two issues have been identified with the plum 360 infusion system involving the distal occlusion auto restart (doar) feature and preventative maintenance (pm) due notification.Issue 1 - if the doar feature is enabled and a distal occlusion occurs, the pump will be in a "paused" state. if a malfunction alarm occurs while the pump is in the paused state waiting for the distal pressure to decrease, the pump cannot be turned off nor delivery restarted until the battery is discharged or disconnected. once the battery is recharged or reconnected, the pump can be returned to clinical service.Issue 2 - when the pm screen is accessed from the main biomed settings menu on pumps that have accumulated a total delivery time greater than 1500 hours, the user will not be able to interact with the pump and the pump must be power cycled. once this is done, the pump can be returned to clinical service. there have been no reports of a serious injury or death related to these issues.
  • 조치
    For Issue 1: Hospira is providing work around instructions for users to follow as a interim measure. For Issue 2: Hospira is advising users to not enable the optional Preventative Maintenance Due Notification feature. A software update will be implemented as a permanent correction.

Device

Plum 360 Infusion System
  • 모델명 / 제조번호(시리얼번호)
    Plum 360 Infusion SystemSoftware version: 15.10.00.010List Number: 30010ARTG Number: 234421
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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