Events

All Plum A+ family of Infusers 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Hospira 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2011-10-04
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111005.html
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Field safety notice: hospira all plum a+ family of infusers hospira has issued urgent device recall on plum a+™ family of infusers. the manufacturer has received customer reports involving two safety issues: (1) rebooting of the infusion pumps, and (2) the incorrect seating of the regulatory closer potentially causing unrestricted flow. the first issue is related to the continuous recycling and/or rebooting of plum a+ devices when the "backlight intensity" and/or "display contrast" settings for the lcd display have been adjusted from default setting. this condition can cause a delay in therapy because the clinician would not be able to start the device due to the continuous recycling and/or rebooting. the second issue is related to incorrect seating of the regulator closer that potentially causes unrestricted flow of the infusion pump when the cassette door is opened. the condition may lead to life-threatening adverse events. to correct the issues, hospira will provide software upgrade and technical checkups to affected customers. according to the local supplier, plump a+ infusion pumps have been distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

All Plum A+ family of Infusers
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Hospira All Plum A+ family of Infusers
  • Manufacturer
    Hospira

Manufacturer

Hospira
  • 제조사 모회사 (2017)
    Pfizer
  • Source
    DH