Events

Electric infusion pump administration set_IIa 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 BD Switzerland Sarl 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
    23250
  • 사례 시작날짜
    2018-06-28
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: CareFusion New Zealand 313 Limited, Unit 14, 13 Highbrook Drive, East Tamaki, AUCKLAND
  • 원인
    The bd alaris infusion pump administration sets require priming prior to use as described in the directions for use (dfu). the manufacturer has identified a potential issue with the bd alaris infusion pump administration sets manufactured during january 2017 through march 2018. the issue pertains to the back check valve and the ability to prime the administration sets. the cause leading to this issue are., 1. excessive solvent used to connect the tubing to the back check valve leading to an obstruction of the fluid path, thus preventing the priming of the set., 2. a higher cracking pressure of the back check valve.
  • 조치
    Manufacturer to issue advice regarding use

Device

Electric infusion pump administration set_IIa
  • 모델명 / 제조번호(시리얼번호)
    Model: BD Alaris™ Primary set, 2 SmartSite Y ports, 1 BCV 294cm, BD Alaris™ Primary set, 2 SmartSite Y ports, 1 BCV 294cm, BD Alaris™ Primary set, 3 SmartSite Y ports, 1 BCV 320cm, BD Alaris™ Primary set, 5 SmartSite Y ports, 1 BCV 349cm, Affected:
  • Manufacturer
    BD Switzerland Sarl

Manufacturer

BD Switzerland Sarl