Events

HeartWare HVAD Controllers and Heartware 1435 DC Adapters 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-2017-RN-00358-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-08-29
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00358-1
  • 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 has developed an updated heartware hvad system controller following two previously communicated urgent field safety notices that occurred in april 2015 and april 2016. with the introduction of the updated hvad controller, also referred to as controller 2.0, heartware is initiating removal procedures for previous generation heartware hvad controllers with serial numbers lower than con300000, and all heartware dc adapters, product code 1435 (all serial numbers), which are incompatible with the new hvad controller. the removal of these hvad controllers and dc adapters will occur concurrently with the introduction of the new hvad controller.The new hvad controller includes enhancements to address the potential safety issues identified in april 2015 and 2016.
  • 조치
    1. Review the HeartWare supplied notice/forms, & forward the notice to individuals who need to be aware of its contents. 2. Complete, sign & return the supplied Acknowledgement Form to HeartWare. 3. Complete training that will be scheduled & conducted by HeartWare, which is required before new HVAD Controllers will be distributed. Patients must be educated on using the new HVAD Controller by hospital staff who have received training from HeartWare. Do not exchange current HVAD Controllers and DC Adapters until after this training. 4. Quarantine & replace affected HVAD Controllers, DC Adapters, IFUs, Emergency Responder Guides & Patient Manuals in hospital inventory after training is complete. 5. Notify and schedule an appointment for each patient ASAP to exchange their controllers. 6. Return all quarantined HVAD Controllers & DC Adapters to HeartWare. 7. Once affected product has been identified and returned, complete & return the supplied Completion Form to HeartWare.

Device

HeartWare HVAD Controllers and Heartware 1435 DC Adapters
  • 모델명 / 제조번호(시리얼번호)
    HeartWare HVAD Controllers and Heartware 1435 DC AdaptersHeartWare HVAD ControllersSerial Numbers below CON3000000Heartware 1435 DC AdaptersAll Serial NumbersARTG Number: 291465
  • 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