Events

HeartWare Controller (Ventricular assist device) 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-2015-RN-00001-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-01-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00001-1
  • 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
    In 2013, heartware advised clinicians (tga reference: rc-2013-rn-00438-1) on measures to take in relation to patient safety risks associated with electrostatic discharge (esd) following two incidents of patient deaths where the electrostatic discharge (esd) was suspected to cause or contribute to data corruption in the pump motor controller resulting in a loss of commutation.The risk of injury associated with esd includes the interruption of circulatory support due to a pump stop. since the 2013 field safety corrective action, heartware have received reports of one additional death and one additional serious injury in which esd may have caused or contributed to data corruption in older controllers resulting in the loss of commutation to pump motors, which ultimately led to pump stops. the affected controllers exhibit a higher susceptibility to esd than newer controllers.
  • 조치
    Clinicians are requested to inspect inventory and quarantine all affected controllers. For patients who possess affected Controllers (both primary and backup) Clinicians are advised as follows: (a). For Primary Controllers: Review the applicable risks and if medically advisable, exchange the affected Controller under medical supervision with a new Controller (serial number CON005473 or higher). (b). For Backup Controllers: Contact the patient and arrange to have the backup Controller replaced with a new Controller (serial number CON005473 or higher). A HeartWare representative will contact the clinicians to assist with this process and to help replace affected Controllers where necessary. This action has been closed-out on 14/07/2016.

Device

HeartWare Controller (Ventricular assist device)
  • 모델명 / 제조번호(시리얼번호)
    HeartWare Controller (Ventricular assist device)Product Codes:1400, 1401XXRange of Serial Numbers: CON000001 through CON005472ARTG 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