Events

HeartWare HVAD Pump Implant Kit 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
    2013-02-19
  • 사례 출판 날짜
    2013-02-19
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130219.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: heartware hvad pump implant kit the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning heartware hvad pump implant kit. below please see the details of the affected devices: product code: 1100, 1102, 1104, 1205 serial no.: hw001‐hw3827 and hw10000‐hw10675 according to heartware, an investigation of customer complaints has confirmed a small number of events (11 of approximately 2900 implants) where the rear portion of the hvad pump’s driveline connector housing becomes partially separated or fully separated from the front portion of the driveline connector. in the unlikely event of a separation, a repair may be necessary. if left unattended, electrical connection to the controller could be affected and a stop alarm could result. heartware reported that none of the 11 confirmed events resulted in harm to the patients affected. heartware is implementing manufacturing process changes to prevent recurrence of this event. meanwhile, users are advised to inspect the patient’s driveline connector at each routine clinic visit. for details, please refer to mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con234577 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 february 2013.

Device

HeartWare HVAD Pump Implant Kit
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: HeartWare HVAD Pump Implant Kit
  • 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