Events

CADD Legacy 1, Model 6400 Ambulatory Infusion Pump 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Smiths Medical Australasia Pty Ltd 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
    RC-2017-RN-01440-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2017-11-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01440-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    Smiths medical became aware that a number of cadd legacy 1, model 6400 ambulatory infusion pumps, may contain non-matching serial numbers. specifically, the label attached to the back of the pump may list a serial number that does not match the correct serial number programmed into the software of the pump. the non-matching serial number issue does not impact the functionality of the infusion pumps. the risk to patient health as a result of this issue is negligible.
  • 조치
    Smiths Medical is advising users to determine if the serial number on the back of the pump matches the electronic serial number programmed into the pump. If the serial numbers do not match, the pumps are to be returned to Smiths Medical.

Device

CADD Legacy 1, Model 6400 Ambulatory Infusion Pump
  • 모델명 / 제조번호(시리얼번호)
    CADD Legacy 1, Model 6400 Ambulatory Infusion Pump Product Number: 21-6400-51Serial Numbers: 410006, 410007, 410008, 410009, 410010, 410011, 410012 ARTG Number: 109467
  • Manufacturer
    Smiths Medical Australasia Pty Ltd

Manufacturer

Smiths Medical Australasia Pty Ltd