Events

HeartWare Ventricular Assist System batteries 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-2014-RN-00510-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-05-05
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00510-1
  • 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 seen an increase in reported heartware system power management complaints related to both premature battery failure and routine battery handling. premature or unrecognised deterioration of battery capacity or lapses in recommended power management pose a risk to the patient and, although rare, may result in serious injury or death. this action is intended to provide patients and healthcare providers with information to recognise batteries with less than two hours of run time, re-emphasise instruction on actions to take when battery alarms occur and reinforce proper power management. early recognition of premature battery depletion, patient training and close attention to recommended power management practices are crucial to reduce patient risk.
  • 조치
    HeartWare is providing information to assist patients and health professionals to monitor battery performance and recognise abnormal behaviour. Health professionals are advised to reinforce the recommended practices for early detection of abnormal battery behaviour and effective power management with their patients. The customer letters identifies the steps to verify that all patients with the HeartWare Batteries are managing their power sources in a safe manner and that batteries are handled in accordance with the Instructions for Use. HeartWare is also advising that complaints will continue to be closely monitored to ensure that the HeartWare System functions as intended and to assess the effectiveness of this field correction. HeartWare will continue to investigate prematurely depleting batteries and will take additional actions as appropriate.

Device

HeartWare Ventricular Assist System batteries
  • 모델명 / 제조번호(시리얼번호)
    HeartWare Ventricular Assist System batteriesProduct Code: 1650All HeartWare Battery Serial NumbersARTG 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