Events

SynchroMed II Infusion System and Model 8870 Software Application Card used in the 8840 N’Vision Clinician Programmer SynchroMed II Infusion System 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Medtronic Australasia 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-00065-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-01-25
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00065-1
  • 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
    This action is a follow up to the july 2013 communication regarding the synchromed ii priming bolus function and to inform that medtronic is updating the model 8870 software application card as well as the synchromed infusion system labelling to address the issue. the software update will change the value displayed on the 8840 programmer for the synchromed ii pump tubing volume from 0.199 ml to 0.140 ml. over delivery of drug during priming bolus has the potential to lead to overdose symptoms in some patients. this software change mitigates the potential for unintended over-delivery of drug while still ensuring prompt therapy initiation. the synchromed ii infusion system manuals were updated for the priming bolus function, and new guidelines for priming have been implemented.
  • 조치
    Doctors are advised to continue to use the current software card and its displayed tubing volume until the Medtronic Representative has exchanged the current card with the new software card (new version is BBU01). New guidelines in labelling regarding priming bolus are identified in the customer letter and the attachment provided with the letter.

Device

SynchroMed II Infusion System and Model 8870 Software Application Card used in the 8840 N’Vision ...
  • 모델명 / 제조번호(시리얼번호)
    SynchroMed II Infusion System and Model 8870 Software Application Card used in the 8840 N’Vision Clinician Programmer SynchroMed II Infusion SystemARTG Number: 977708840 N’Vision Clinician ProgrammerARTG Number: 104700
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • 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
    DHTGA