Events

HeartWare Ventricular Assist System (intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end stage heart failure) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Heartware Pty Limited 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-2013-RN-00126-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-02-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00126-1
  • 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
    There is potential for the rear portion of the hvad pump's driveline connector housing partially or fully separating from the front portion of the driveline connector. if unattended, the electrical connection to the controller could be affected and loss of mechanical circulatory support may occur.
  • 조치
    HeartWare are advising medical practitioners to inspect the patients drive line connector at each routine clinic visit. If the rear portion of the driveline connector housing is partially separated from the front portion, hand tighten the front and rear portions together. Contact your HeartWare Representative to arrange for an inspection and permanent repair by a HeartWare Clinical Engineer. If the driveline connector housing is completely separated secure the driveline connector housing to the controller with a splint to maintain a secure connection until a repair can occur. Where the connector/controller connection is secured by splinting the controller and connector with tongue depressors and electrical tape. Contact your HeartWare Representative to arrange for an inspection and permanent repair by a HeartWare Clinical Engineer. Further information can be found ont he TAG website at https://www.tga.gov.au/alert/heartware-ventricular-assist-system

Device

HeartWare Ventricular Assist System (intended for use as a bridge to cardiac transplantation in p...
  • 모델명 / 제조번호(시리얼번호)
    HeartWare Ventricular Assist System (intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end stage heart failure)Product Code: 1100, 1101, 1102, 1104, 1205Serial Numbers: HW001 to HW3827 and HW10000 to HW10675ARTG Number: 181875
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    Heartware Pty Limited

Manufacturer

Heartware Pty Limited
  • 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