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
    2013-02-21
  • 사례 출판 날짜
    2013-02-21
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130221a.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 (fluid shield- fluid ingress) the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning plum a+ family of infusers manufactured by hospira uk limited. the affected list numbers are: 11005 (plum a+ hyperbaric infusion system) 11971, 12391 (plum a+ single channel infusion system) 12348, 12618 (plum a+3 infusion pump system) 20678 (plum a+3 infusion pump with hospira mednet software) 20792 (plum a+ infusion pump with hospira mednet software) according to the manufacturer, there is a potential for fluid ingress into the plum a+ mechanism assembly. this issue may result in the device being unable to recognize installed tubing or installed cassettes, or cause valve cassette test failures. subsequently, audible and visual alarms may be triggered and lead to a delay or interruption in therapy. hospira explained that the severity of the problem is dependent upon the underlying condition of the patient and the treatment being prescribed. significant injury or death can be resulted. hospira has identified multiple root causes for this issue, including spillage/ contamination on the pressure sensing system from iv and cleaning fluids, design robustness of the fluid shield and fluid contamination/ build-up leading to misalignment of the pressure sensor pins with the cassette disphragm. while hospira is carrying out remediation activities to address the problem, customers are reminded to clean the infuser weekly according to the plum a+ system operations manual. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con234577 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 21 february 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