Events

RAPIDPoint 500 Blood Gas Analyzer 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens Healthcare 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-00700-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-07-31
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00700-1
  • 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
    Siemens is informing customers of potential issue when both ports (serial and ethernet) are configured to transmit data, the data stream from one port could potentially affect the data stream from the other port. this could cause the message received by the lis (data management system) to include either: duplicate data, missing data and data from a different patient. the risk to health is limited to the extremely unlikely situation in which an analyte is switched between two patients. a transposed sodium, potassium, glucose, lactate, carboxyhemoglobin, methemoglobin, or neonatal bilirubin result may lead to a potential risk to health when the true value is critical.In all cases, the probability of occurrence is extremely unlikely due to the low frequency of the software issue and correlation with patient clinical presentation, history, and concurrent laboratory testing.
  • 조치
    Siemens is providing end users with instructions on how to disable Dual Port LIS transfer. The resolution of this issue will be addressed in the next software update. This action has been closed-out on 01/03/2018.

Device

RAPIDPoint 500 Blood Gas Analyzer

Manufacturer

Siemens Healthcare Pty Ltd