Events

Plum 360 Infusion Pump, with 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-2016-RN-01199-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-09-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01199-1
  • 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 identified an issue where the user interface (ui) does not update to reflect a calculated dose value. this only occurs when using a dosing unit in the mmol or units families. if the 1st digit entered in the rate or vtbi field results in a calculated dose that is less than the pump limit (0.001), the pump will dash out (“---“) the dose field & display the message ”minimum hard limit dose is 0.001 press [c] key to clear entry”. this is expected behaviour. if the calculated dose is above 0.001 the pump will display the correct dose value. the issue occurs when entering additional digits in the rate or vtbi fields. if the dose field is dashed out, the ui will not display the newly calculated dose when subsequent digits are entered. despite this, the dose value is calculated correctly; but the ui does not update to reflect the correct calculated dose value.This issue does not occur if the dose value is directly entered in the dose field as opposed to being calculated by the pump.
  • 조치
    Hospira is providing users with work around instructions to follow as an interim measure. Users can enter the dose manually to over-ride the dash out. A software update will be implemented as a permanent correction.

Device

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

Manufacturer

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