Events

HeartWare HVAD Systems 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
    2018-05-04
  • 사례 출판 날짜
    2018-05-04
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180504.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: medtronic heartware hvad systems medical device manufacturer, heartware (now a part of medtronic), has issued a medical device safety alert concerning its hvad systems. the affected devices are identified as the following: - controller/ controller kits (model number: 1400, 1401, 1403, 1407, 1420; all serial numbers) dc adapter (model number: 1435, 1440; all serial numbers) ac adapter (model number: 1425, 1430; all serial numbers) battery pack (model number: 1650; all serial numbers) the manufacturer informs healthcare professionals of the potential for a transient interruption of the electrical connection between an hvad system power source (battery, ac adapter, or dc adapter) and the hvad controller that may result in unintended power switching to the secondary power source and/or unexpected audible tones ("beeping"). this interruption, which occurs while the power source remains physically connected, is due to oxidation of connecting surfaces between a power source connector and the controller's power source socket, and typically lasts 1-2 seconds. unexpected beeping occurs when the interruption automatically resolves and may cause confusion to the patient or caregiver, as the controller may display sufficient battery capacity or acidc connectivity at the time of the audible tone. a critical battery alarm may also be momentarily displayed due to this phenomenon. according to the manufacturer, the projected occurrence rate of unexpected power source switching with the hvad system over a 2-year period on a per patient basis is approximately 25%. approximately 97% of reported occurrences of this issue resulted in no patient symptoms. however, the potential harm associated with transient power source interruptions can vary, depending on whether two power sources are connected (as instructed in the instructions for use and patient manual) versus a single source, and the patient's underlying health. the per patient probability of serious adverse events due to this issue is approximately 0.003. the manufacturer has continued to develop and implement enhancements into the hvad system to improve power source connectivity and reduce the potential for unintended power source switching. affected users should follow the manufacturer’s recommendations for effective power source management of the hvad systems. 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 4 may2018.

Device

HeartWare HVAD Systems
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Medtronic HeartWare HVAD Systems
  • 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