Events

HeartWare Ventricular Assist System 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Heartware 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-2018-RN-00256-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2018-05-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00256-1
  • 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
    Heartware, now a part of medtronic, has identified 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 ac/dc connectivity at the time of the audible tone. a critical battery alarm may also be momentarily displayed due to this phenomenon.
  • 조치
    Medtronic is developing mitigations for current patients and future system enhancements have been identified and pending approval. Medtronic will inform users when these have been made available. In the interim, Medtronic is providing the following recommendations for power source management of HVAD Systems: - Reinforce the importance of always ensuring TWO power sources (AC or DC adapter plus a battery, OR two batteries) are connected at all times (except when changing a power source) - Reinforce best practice guidance for managing power sources when going to sleep and awakening - Instruct patients to report any persistent, unexpected audible tones to the VAD team for additional instructions Update June 2018: Medtronic HeartWare Field Representatives will coordinate with surgeons to arrange for service of patient's HVAD power source components. This will include application of a lubricant to all HVAD power sources. It is expected that this will be a one-time field service.

Device

HeartWare Ventricular Assist System
  • 모델명 / 제조번호(시리얼번호)
    HeartWare Ventricular Assist SystemController/Controller KitsModel Numbers (may contain various suffixes): 1400, 1401, 1403, 1407 and 1420DC AdapterModel Numbers (may contain various suffixes): 1435 and 1440AC AdapterModel Numbers (may contain various suffixes): 1425 and 1430Battery PackModel Numbers (may contain various suffixes): 1650All Serial Numbers of the above modelsARTG Number: 181875
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    Heartware Pty Ltd

Manufacturer

Heartware Pty Ltd
  • 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
    DHTGA