Events

HeartWare HVAD Pumps 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 HeartWare Incorporation 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
    2016-08-12
  • 사례 출판 날짜
    2016-08-12
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_201608012b.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 pumps medical device manufacturer, heartware incorporation, has issued a medical device safety alert concerning its hvad pumps. the affected devices are identified as follows:- model number: 1104gb serial number: sterile, un-implanted stock in inventory with serial numbers prior to hw25838 the manufacturer has reviewed certain complaints related to the hvad system and announced a voluntary recall of specified implant kits (pumps) in hospital inventory, which may be more susceptible to electrical faults if the driveline becomes contaminated. according to the manufacturer, contamination of the driveline-to-controller connector can occur during the implant procedure or post operatively from fluid ingress into the driveline. connector contamination of the driveline has been seen to occur most often in the first 30 days post implant. affected devices that have already been implanted into a patient are not subject for removal. the presence of fluid or foreign material at the driveline/controller connector may impact the function of the pump and controller. specifically, foreign material at the driveline/controller connector could lead to electrical faults and connection failures. in these scenarios, potential risks include interruption of circulatory support due to a pump stop, which could cause serious injury or death. the manufacturer has implemented manufacturing process improvements designed to prevent driveline connector contamination in new implant kits. users are advised not to attempt to repair or service any components of the heartware system. if the heartware system equipment malfunctions, they should promptly contact their local representative. according to the local supplier, the affected serial numbers are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 12 august 2016.

Device

HeartWare HVAD Pumps
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: HeartWare HVAD Pumps
  • Manufacturer
    HeartWare Incorporation

Manufacturer

HeartWare Incorporation
  • 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