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-00902-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-08-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00902-1
  • 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 may 2014, heartware distributed recall for product correction letter (tga ref: rc-2014-rn-00510-1/ heartware ref: fsca apr2014.1) following an increase in reported power management complaints related to earlier than expected battery depletion. information on early battery depletion, identification of potentially faulty batteries, and recommended practices for power management were provided in the recall for product correction letter.Heartware is expanding the action to include the recall of batteries produced within the serial number ranges: bat000001 to bat039999 and bat090000 to bat099999. batteries produced in these ranges are more likely to exhibit premature or unrecognized deterioration of battery capacity, which poses a risk to the patient since it may result in a pump stop.
  • 조치
    HeartWare is requesting their clinicians to review their hospital’s current inventory and remove and quarantine any affected batteries. At each patient’s next regularly scheduled visit, inspect their batteries and replace affected batteries with batteries having serial numbers BAT040000 to BAT089999 or BAT100000 and above. If a patient does not have a regular visit scheduled within the next 90 days, contact that patient by telephone to check the serial numbers of the patient’s batteries. This action has been closed-out on 13/10/2016.

Device

HeartWare Ventricular Assist System batteries
  • 모델명 / 제조번호(시리얼번호)
    HeartWare Ventricular Assist System batteriesProduct code: 1650Serial number range for the affected batteries: BAT000001 to BAT039999; BAT090000 to BAT099999ARTG 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