Events

SynchroMed II Model 8637 Implantable Drug Infusion Pump 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-2014-RN-00357-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2016-11-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00357-1
  • 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
    Medtronic has detected an upward shift in reports of over-infusion, defined as an infusion rate exceeding the programmed rate by more than 14.5% as described in the labelling. when over-infusion occurs, it will result in a volume discrepancy at pump refill, where the volume withdrawn is less than the volume expected. the device does not measure actual reservoir volume and in the context of over-infusion the reservoir may empty entirely without activating an alarm. over-infusion can result in a life-threatening overdose and/or drug withdrawal resulting from premature emptying of the pump. the onset of over-infusion has occurred as early as five months after implant and throughout the service life of the pump. reports indicate that once a pump has started to over-infuse, infusion rates can continue to increase, in some cases abruptly. the device does not measure actual reservoir volume and in the context of over-infusion the reservoir may empty entirely without activating an alarm.
  • 조치
    Due to the low reported rate of occurrence of this issue and the inability to predict which pumps may be at risk, Medtronic is not recommending prophylactic replacement of pumps. Through the Hazard alert letter, Medtronic is recommending physicians on the appropriate management of patients implanted with the affected SynchroMed II pumps. Medtronic continues to investigate this issue and will be providing updates as more information becomes available. For further information, please refer to http://www.tga.gov.au/safety/alerts-device-medtronic-synchromed-140328.htm .

Device

SynchroMed II Model 8637 Implantable Drug Infusion Pump

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