Events

HeartWare™ Ventricular Assist System 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 HeartWare 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
    2012-01-04
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120104b.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
    Field safety notice: heartware™ ventricular assist system the uk medicines and healthcare products regulatory agency (mhra) issued a field safety notice to alert healthcare providers and customers regarding the heartware® controller (product code: 1400) manufactured by heartware, inc. an investigation of a single customer report has confirmed that it is possible in a specific circumstance for medium priority (low flow, high power, and suction) alarm limits to be exceeded without an audible notification or a visible alarm message being displayed on the heartware controller. the reported condition will only occur if the controller has lavare cycle turned on and then, when connected to a monitor, the lavare cycle is turned off during the initial eight seconds of the cycle. there are no reported adverse events or complications associated with the report, and the alarm suppression is not associated with resetting (short-restart) of the hvad pump. a clinical risk to a patient would most likely occur if there were a vad thrombus or occlusion event that caused high watts or low flow. the clinical risk could include failure to provide a warning to the patient that a low flow state existed. such a state would cause symptoms such as hematuria or heart failure to occur and lead the patient to seek medical attention. while death under such circumstance is not likely, low flow ischemia to various organs (e.G. kidneys) could result in reversible impairment that could be corrected by restoring full flow. according to the manufacturer, the affected products have not been distributed in hong kong. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected products, please contact your supplier for further information and necessary actions.

Device

HeartWare™ Ventricular Assist System
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: HeartWare® Ventricular Assist System
  • Manufacturer
    HeartWare

Manufacturer

HeartWare
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH