Events

HeartWare Ventricular Assist System, Controller 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
    2013-05-20
  • 사례 출판 날짜
    2013-05-20
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130520a.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 ventricular assist system, controller the australia therapeutic goods administration (tga) has posted a medical device safety alert concerning heartware controller, component of a ventricular assist device. the affected product codes are 1400 and 1401au. all serial numbers are affected. heartware has advised of a recent incident involving a patient death thirty-four months post heartware ventricular assist system implantation. the patient was found alone and unresponsive with the controller alarming approximately three hours post event. log file analysis confirmed that the pump had stopped. functional testing of the returned controller showed that the device (including motor control circuits) performed all functions as intended within specification and with no fault alarms or errors. the exact cause of the event cannot be conclusively determined. however, heartware suspects that an electrostatic discharge through the exposed controller power ports during battery replacement caused or contributed to data corruption in the pump motor controller resulting in a loss of commutation in which the motor control software was no longer driving the pump’s motor controller circuit and leading to a pump stop. physicians are reminded of the following: be aware of electrostatic discharge and its potential to cause disruptive and possibly fatal faults to susceptible patients. avoid devices and conditions that may induce strong static discharges (for example, television or computer monitor screens) as electrostatic discharges can damage the electrical parts of the system and cause the left ventricular assist device to perform improperly or stop. always have a backup controller handy and a care giver nearby when changing power sources or controllers. be watchful for unusual changes in power or flow alarms for a period of time following equipment change. according to the local supplier, the affected products were not distributed in hong kong. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-00438-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 may 2013.

Device

HeartWare Ventricular Assist System, Controller
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: HeartWare Ventricular Assist System, Controller
  • 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