CDI H/S Cuvettes 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Terumo Cardiovascular Systems 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
    2016-01-13
  • 사례 출판 날짜
    2016-01-13
  • 사례 국가
  • 사례 출처
    DH
  • 사례 출처 URL
  • 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: terumo cvs cdi h/s cuvettes medical device manufacturer, terumo cardiovascular systems (terumo cvs), has issued a medical device safety alert concerning its cdi h/s cuvettes. the manufacturer 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. the manufacturer has determined that this issue originated from a supplier process related to a component of the cdi h/s cuvettes, and has taken corrective action. there are no reported injuries as a result of this issue. if failure of the cdi h/s cuvette connection is recognized 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 hematocrit/saturation (h/sat) values (which may be contrary to hospital protocol). the manufacturer recommends affected users to take the following actions:- upon attachment of the cdi h/s cuvette to the cdi h/s probe on the cdi system 500 monitor, verify that a connection is established prior to initiating cpb. this can be confirmed visually on the cdi system 500 monitor by placing the unit in "operate" mode. if the cdi h/s cuvette does not establish connection to the cdi h/s probe (as evidenced by the “h/s disconnect at cuvette” error message on the cdi system 500 monitor display), try repositioning the cuvette in the probe head. if repositioning the cuvette in the probe head does not result in a successful connection and error-free monitor display, replace the cdi h/s cuvette using aseptic technique. if users experience an "h/s disconnect at cuvette" error message that they are not able to resolve, they should follow their complaint reporting protocol and contact the manufacturer. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 13 january 2016.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Terumo CVS CDI H/S Cuvettes
  • Manufacturer

Manufacturer