Events

Cardiopulmonary Bypass Packs containing Terumo CDI H/S Cuvettes used with the CDI Blood Parameter Monitoring System 500 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Lovell Surgical Supplies International 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-2016-RN-00187-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-02-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00187-1
  • 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
    The terumo cdi h/s cuvette is included in some cardiopulmonary bypass packs supplied by lovell surgical supplies international.Terumo cardiovascular systems (terumo cvs) has received complaints of the cdi system 500 monitor displaying the “h/s disconnect at cuvette” error message when the cdi h/s cuvette does not make a proper connection to the cdi h/s probe. in this situation, blood parameter values for hct, hgb, and so2 do not display. if failure of the cdi h/s cuvette connection is recognised after initiation of cardiopulmonary bypass (cpb), the clinician will have to choose between changing out the cuvette (which requires the interruption of cpb for an indeterminate amount of time) or relying on intermittent discreet blood gas analysis values to trend haematocrit/saturation (h/sat) values.
  • 조치
    Lovell Surgical Supplies is providing users additional instructions to check the cuvette is properly connected before use. Thia action has been closed-out on 19/01/2016.

Device

Cardiopulmonary Bypass Packs containing Terumo CDI H/S Cuvettes used with the CDI Blood Parameter...
  • 모델명 / 제조번호(시리얼번호)
    Cardiopulmonary Bypass Packs containing Terumo CDI H/S Cuvettes used with the CDI Blood Parameter Monitoring System 500Multiple Product Codes affectedMultiple Batch Numbers affectedARTG Number: 158341
  • Manufacturer
    Lovell Surgical Supplies International Pty Ltd

Manufacturer

Lovell Surgical Supplies International Pty Ltd