Events

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
    2013-01-09
  • 사례 출판 날짜
    2013-01-09
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130109.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
    Medical device safety alert: hospira plum a+ family of infusers the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning plum a+ family of infusers, manufactured by hospira, inc. hospira issued a field safety notice to inform users that the door roller assembly on the plum a+/a+3 infuser family has the potential to break which can lead to possible unrestricted flow and/or over-delivery during the removal of the iv administration set’s cassette from the pump. the iv administration set’s cassette contains a flow regulator that is designed to close upon cassette removal to prevent accidental flow. in the event the door roller assembly is broken the regulator closer may not close properly and unrestricted flow and/or over-delivery can occur which has the potential to contribute to life-threatening adverse events. to correct the issue,hospira has redesigned the door roller to improve the strength and reduce the potential for the door roller assembly to break and will arrange a replacement to affected customers for the door rollers. until the door assembly is replaced, the manufactureradvisesthe users to inspect the door roller assembly prior to loading a cassette for signs of damage.If the door roller or axel appears loose, broken, or missing, then the device needs to be taken out of services until the door assembly is replaced with a corrected door assembly. furthermore, hospirarecommendsthe users to keep the cassette door securely closed while the product is not in use to avoid cassette door damage. additionally, to avoid the accidental flow, close the slide clamp or cair roller clamp on the administration set prior to opening the door. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/ con216883 if you are in possession of the product, please contact your supplier for necessary actions. posted on 9 january 2013.

Device

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

Manufacturer

Hospira
  • 제조사 모회사 (2017)
    Pfizer
  • Source
    DH