Events

HeartMate 3 Left Ventricular Assist System (LVAS)Catalogue Number: 106524INT – LVAS KIT, HM 3 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 St Jude Medical Australia 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-00750-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-06-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00750-1
  • 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
    Abbott has identified reports (1.29% incident rate, with no patient injuries) of errors in communication between the system controller and pump of the heartmate 3 lvas. there is the potential for a communication error which triggers a communication fault advisory alarm on the system controller. abbott has traced the issue to manufacturing variances that could lead to crystallisation formation, which may then disrupt communication between the pump and the system controller. the lvas has a redundant communication line so a complete loss of communication between the system controller and pump will only occur if both lines are affected. the lvas has an on-board diagnostic system that monitors for these conditions several times per second. in this rare situation, the lvas pump will continue to operate as programmed after the point communication is lost. communication between the system controller and pump, including the interface to make pump operating changes, is no longer feasible.
  • 조치
    The following patient management advice is provided to physicians. For loss of a single communication line (Driveline COM Fault), accompanied by an advisory alarm, the Driveline COM Fault advisory alarm can be manually silenced on System Controller for 4 hrs with 1 functioning communication line or permanently silenced (at discretion of physician) via System Monitor (assuming alarm persists). For loss of both communication lines (COM Fault), noted by presence of COM Fault advisory alarm, the COM Fault advisory alarm can be manually silenced on System Controller for 4 hrs or via System Monitor for 24 hrs. The COM Fault advisory alarm will display even if Driveline COM Fault advisory alarm is permanently silenced. Remind patients to contact their VAD Coordinator in the event an advisory alarm appears on their System Controller. Physicians managing patients subject to an Advisory COM Fault alarm should determine patient care recommendations based on each clinical case.

Device

HeartMate 3 Left Ventricular Assist System (LVAS)Catalogue Number: 106524INT – LVAS KIT, HM 3
  • 모델명 / 제조번호(시리얼번호)
    HeartMate 3 Left Ventricular Assist System (LVAS)Catalogue Number: 106524INT – LVAS KIT, HM 3Serial Number: MLP-002965Supplied through the Special Access Scheme
  • Manufacturer
    St Jude Medical Australia Pty Ltd

Manufacturer

St Jude Medical Australia Pty Ltd
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DHTGA