Events

Lifeshield Primary Plumset 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Hospira 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert / Field Safety Notice
  • 사례 ID
    MDA/2013/081R
  • 사례 연번
    CON346681
  • 날짜
    2013-12-05
  • 사례 출판 날짜
    2013-12-05
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON346681?tabName=allTabs
  • 비고 / 경고
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • 데이터 추가 비고
  • 원인
    Risk of embolism and allergic reaction due to exposure to particulates and non-biocompatible materials, especially during administration of parenteral lipids. due to a manufacturing fault, these devices may be fitted with an incorrect filter which has not undergone biocompatibility testing. hospira issued a field safety notice (fsn) dated 22 october 2013, but has not received confirmation from enough users that they have received and acted on this information.
  • 조치
    Identify, quarantine and do not use affected product lots. Use alternatives until new product is available from Hospira. Liaise with Hospira for the collection of affected product. Complete and return the reply form to Hospira. Report any adverse incidents to Hospira and the MHRA.

Device

Lifeshield Primary Plumset
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Intravenous pump set: Lifeshield Primary Plumset. Specific list numbers and lot numbers are affected. List number Lot numbers Set description 14000-92-28 27112-5H 30079-5H Lifeshield, latex-free, non-DEHP, Primary Plumset, 15 micron filter in sight chamber, Prepierced Y-site, 272 cm 14001-92-38* 28187-5H Lifeshield, latex-free, non-DEHP, Primary Plumset, 15 micron filter in sight chamber, Clave port, Clave Y-site, 272 cm *the equivalent NHS Supply Chain code for this list number is FSB1314 (England only). NHS Supply Chain has sent its own customer notice about this recall (reference NHS SC 32).
  • Manufacturer
    Hospira

Manufacturer

Hospira
  • 제조사 모회사 (2017)
    Pfizer
  • Source
    MHRA