Events

abl90 flex 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Radiometer 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2018-05-21
  • 사례 출판 날짜
    2018-05-21
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180521b.html
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: radiometer abl90 flex medical device manufacturer, radiometer, has issued a medical device safety alert concerning its abl90 flex (393-090) analyzers running software versions 3.3 mr1 or lower. the manufacturer has become aware that the abl90 flex in a very rare specific situation can aspirate cal 2 solution instead of rinse solution. the specific situation can occur when the following take place: the analyzer is in ready mode operator lifts the inlet and then closes it again, thereby initiating a rinse immediately after lifts the inlet and quickly closes it again in this situation, it will lead to several parameters reported wrong during the following measurements. some of the parameters will not have an error message or question mark indicating a problem with the result. the wrong reporting will continue until the analyzer flow selector has reset. according to the manufacturer, the flow selector will reset as part of the automatic error removal process performed during repeated automatic calibrations, qc measurements or during installation of the solution pack. it will release a new software version 3.4 (933-470) for the abl90 flex analyzer, which correct this issue. the affected customers are advised to take the following actions: inform users of the abl90 flex analyzer that the inlet is not to be repeatedly lifted and closed. if this is done anyway the easiest way to reset the analyzer flow selector manually is to re-install the solution pack. follow the procedure described in the instruction for use for installation of a solution pack. re-use the same solution pack. review previous results, where cna+ and ccl- results are off from the expected results with the values found in table 1 of the field safety notice. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 21 may 2018.

Device

abl90 flex
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Radiometer ABL90 FLEX
  • Manufacturer
    Radiometer

Manufacturer

Radiometer