Events

HeartWare HVAD System Controller/ Controller Kits 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 HeartWare 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2018-08-31
  • 사례 출판 날짜
    2018-08-31
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180831.html
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: medtronic heartware hvad system controller/ controller kits medical device manufacturer, heartware (a part of medtronic), has issued a medical device safety alert concerning its heartware hvad system controller/ controller kits [model numbers: 1403, 1407, 1420; serial number range: con300175 – con320540]. the manufacturer has become aware that the controller units in the range mentioned above may not meet the labeled standard for protection against water or fluid ingress. some units have the potential to develop hairline cracks at the power ports of the controller housing. the cracks may allow for water or fluid ingress if the patient does not follow the instructions for use and the patient manual, including use of a water-resistant shower bag to help protect the unit. this can lead to varying degrees of controller malfunction, including pump stop. according to the manufacturer, the cracks were found during manufacturer inspection of product under 10 x magnifications and are not visible without magnification. the root cause was determined to be a latent interaction between the materials used in the housing unit and the nitrile rubber gasket of the power port connector. the manufacturer recommends the following patient manual instructions should be reinforced: patients currently supported by the hvad system should follow all instructions in their patient manuals regarding water or fluid avoidance, which remain unchanged, and understand the importance of always using a shower bag when showering. if a patient encounters a situation in which their hvad system controller is exposed to water or fluid outside of conditions described in the ifu and patient manual, the patient should be advised to contact his/her vad coordinator. if further assistance is needed, clinicians should contact their local supplier. the manufacturer and the independent practitioner quality panel do not recommend proactive controller exchanges as a result of this potential issue. the manufacturer has since resolved this issue in the manufacturing process, and all newly distributed controller units are no longer susceptible to this materials interaction. no other hvad system components are susceptible to the issue. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 31 august 2018.

Device

HeartWare HVAD System Controller/ Controller Kits
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Medtronic HeartWare HVAD System Controller/ Controller Kits
  • Manufacturer
    HeartWare

Manufacturer

HeartWare
  • 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
    DH