Events

HeartWare HVAD 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-2016-RN-00580-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2016-05-11
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00580-1
  • 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 have received reports of loose power and data connectors on the heartware controller, specifically for loose connector ports within the controller.If a power or data connector becomes loose, controllers could become more vulnerable to water damage, which could lead to internal corrosion, electrical issues, reduced speaker volume and connection failures.In these scenarios, potential risks include:- interruption of circulatory support due to a pump stop, which could cause serious injury or death- reduced ability to detect alarms- loss of communication between the controller and heartware monitor.
  • 조치
    HeartWare is advising the clinicians to: 1. Continue to remind the patients currently supported by the HVAD System to follow all instructions in their Patient Manuals including alarm awareness, water avoidance and carefulness when connecting and disconnecting to power and data sources. 2. At the patients’ regularly-schedule appointments, inspect Controllers for loose connectors by gently pressing on each connector and feeling for atypical movement. Do not press hard on the connectors or they could break. If a loose connector is identified, it is recommended that the affected Controller be replaced with a Controller from inventory and contact the local HeartWare representative. If the affected Controller is the patient’s primary Controller, please use discretion as to whether the risks of a Controller exchange outweigh the risks of a Controller with a loose connector. This action has been closed-out on 22/02/2017.

Device

HeartWare HVAD system
  • 모델명 / 제조번호(시리얼번호)
    HeartWare HVAD systemProduct Codes: 1407XXAll HeartWare Controllers affectedARTG 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