Events

OPTI Blood Gas analysers - An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Helena Laboratories Australia 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-2015-RN-00367-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-04-30
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00367-1
  • 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
    Opti medical has identified that when so2 is below 80%, the bias on the thb is outside of their claims for measurement accuracy. the calculated parameters, hct and o2 (ct) are also significantly affected by the thb issue. the root cause is due to a shift in the wavelength of one of the lasers used to measure thb and so2. the shift occurred when opti switched suppliers of the laser.
  • 조치
    End users are advised not to report tHb results from the affected device or use an alternative method to measure tHb when SO2 is below 80%. The Hct and O2(ct) calculated parameters should also not be reported when SO2 is below 80%. Users are strongly recommend to review patient tHb results when SO2 results were below 80% to determine if any adverse events have occurred. A software update is being developed to correct the issue. This action has been closed-out on 09/08/2016.

Device

OPTI Blood Gas analysers - An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    OPTI Blood Gas analysers - An in vitro diagnostic medical device (IVD)- All OPTI CCA-TS2 analyzers (GD7046)- OPTI CCA-TS analyzers (GD7013) with serial numbers 2700 and above - OPTI CCA analyzers (GD7045) with serial numbers 8056 and above- OPTI R analyzers (GD7031) with serial numbers 1334 and aboveARTG Number: 227530
  • Manufacturer
    Helena Laboratories Australia Pty Ltd

Manufacturer

Helena Laboratories Australia Pty Ltd