Events

Plum A+ Pump Version 11.6 and Plum A+ Pump Version 13.4 Med Net ABG Driver (general purpose infusion pump) 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-01039-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-10-11
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01039-1
  • 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 volume control knob located on the back of the infuser may not function as described in the system operating manual; the direction for loud and quiet may be reversed. the manual indicates a clockwise rotation of the knob decreases the volume, however on some devices the alarm volume increases when the knob is turned clockwise. while the device will continue to alarm with an audible tone of at least 50dba at the lowest level, inadvertently setting a low tone may result in an audible alarm that is more difficult to hear.
  • 조치
    Hospira is providing work around instructions and will be updating the Instructions for Use (IFU).

Device

Plum A+ Pump Version 11.6 and Plum A+ Pump Version 13.4 Med Net ABG Driver (general purpose infus...
  • 모델명 / 제조번호(시리얼번호)
    Plum A+ Pump Version 11.6 and Plum A+ Pump Version 13.4 Med Net ABG Driver (general purpose infusion pump)Plum A+ Pump Version 11.6Catalogue number 611239101Number on pump: 12391/11971Plum A+ Pump Version 13.4 Med Net ABG DriverCatalogue number: 612079201Number on pump 20792ARTG Number: 138109
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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