Events

Curlin Medical infusion pump 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Moog Medical Devices Group Inc 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
    19678
  • 사례 시작날짜
    2016-01-19
  • 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: Biomed Limited, 52 Carrington Road, Point Chevalier, AUCKLAND
  • 원인
    Master pumps used to calibrate curlin infusion pumps manufactured or serviced from march 18, 2015 to november 6, 2015 were out of tolerance.Use of affected pumps may cause an over-delivery of medications and solutions at a rate of 1.2 – 6.8% faster than programmed. likewise, the volume to be infused may be depleted earlier than expected, resulting in over delivery of overfill contained in the iv bag, if overfill is present. if overfill is not present, the pump may present an air in line or upstream occlusion alarm once the iv bag has emptied. the pump will stop infusing when either of these alarms occurs.
  • 조치
    Product to be returned to supplier

Device

Curlin Medical infusion pump

Manufacturer

Moog Medical Devices Group Inc