Events

Non-Flow-Stop CADD Medication Cassette Reservoirs 50 and 100mL 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-01299-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-10-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01299-1
  • 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 has become aware that certain non-flow-stop cadd medication cassette reservoirs may have been manufactured with an incorrect pressure plate. this product is designed without an arch, but the defective product has a plate with an arch.There is a risk that under delivery of medication may result from the tubing becoming partially or completely occluded when the cassette is attached to the pump. the clinician is not aware of the issue because the pump will continue to operate as if it is infusing medication without alarming for an occlusion.
  • 조치
    Smiths Medical is advising users to quarantine remaining stock of the affected product for return for credit. It is recommended that users transition to an equivalent flow stop version of the CADD Medication cassettes.

Device

Non-Flow-Stop CADD Medication Cassette Reservoirs 50 and 100mL
  • 모델명 / 제조번호(시리얼번호)
    Non-Flow-Stop CADD Medication Cassette Reservoirs 50 and 100mL50mL CADD Medication CassetteItem Code: 21-7001-24100mL CADD Medication CassetteItem Code: 21-7002-24 100mL CADD Medication Cassette, YellowItem Code: 21-7100-24Multiple Lot Numbers ARTG Number: 145297
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • Manufacturer
    Smiths Medical Australasia Pty Ltd

Manufacturer

Smiths Medical Australasia Pty Ltd