Events

Medtronic DLP Adapters and Pressure Display Sets DLP Extension Line Adapters 20 in length, GDLP Antegrade/Retrograde Adapter, DLP Cardioplegia Adapter with Pressure Port, DLP Pressure Monitoring Extension Line Adaptors, DLP Pressure Disposable Pressure Display Sets 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Medtronic Australasia 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-00805-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-06-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00805-1
  • 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
    Medtronic recently identified small pinholes approximately 1mm or less in diameter in single packaging configuration. medtronic has performed an internal investigation and all products configured and manufactured since march 1 2016 are potentially affected. this result is a potential sterile barrier breach. zero complaints have been received for the affected lots. potential patient harm is infection, which could result in secondary harm if a sterile barrier breach in the packaging is present, but not detected prior to use.
  • 조치
    Medtronic is Recalling affected stock from the Market.

Device

Medtronic DLP Adapters and Pressure Display Sets DLP Extension Line Adapters 20 in length, GDLP A...
  • 모델명 / 제조번호(시리얼번호)
    Medtronic DLP Adapters and Pressure Display SetsDLP Extension Line Adapters 20 in lengthProduct Code: 11001GDLP Antegrade/Retrograde AdapterProduct Code: 13001DLP Cardioplegia Adapter with Pressure PortProduct Code: 15004DLP Pressure Monitoring Extension Line AdaptorsProduct Codes: 25009, 25010DLP Pressure Disposable Pressure Display SetsProduct Codes: 61000, 62000ARTG Numbers: 126007 and 130994
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia 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