Events

Plum 360 Infusion Pump, software version 15.02 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-00001-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-01-05
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00001-1
  • 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 software issues have been identified with the plum 360 infusion pump, software version 15.02, namely:issue 1 - the pump software incorrectly generates a “depleted battery” alarm instead of a “replace battery” alarm when the battery has a near end of life charge capacity. the expected performance of the infusion pump and software is for the infusion pump to generate a “replace battery” alarm when the software has determined the battery has reached a near end of life charge capacity. issue 2 – when ac power is lost and quickly resumed, the pump software incorrectly classifies the event as an e323 alarm condition. this result in an interruption of any ongoing therapy and the infusion pump will restart (reboot).
  • 조치
    Hospira is advising users to connect the infusion pump to AC power and turn the pump on. They are requested to replace the battery if they see the “Replace Battery: Keep Plugged into AC! Service battery / replace pump” message. Users are also requested to replace the battery if they see the “Depleted Battery! Plug into AC now!” message while the pump is in operation. For battery replacement, users are requested to either send it to their in-house engineering department in the first instance and if further assistance is required, to contact the Hospira Service Centre.

Device

Plum 360 Infusion Pump, software version 15.02
  • 모델명 / 제조번호(시리얼번호)
    Plum 360 Infusion Pump, software version 15.02List Number: 30010ARTG Number: 234421
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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