Events

Sapphire Multi-Therapy and Sapphire Epidural Pumps with software versions 11.00 and below 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Hospira Pty Limited 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-2015-RN-01153-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-12-02
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01153-1
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • 데이터 추가 비고
  • 원인
    There may be a delay in delivery of pain medication when using epidural mode with patient bolus on sapphire multi-therapy & sapphire epidural pumps that have software v11.00 or lower installed. on these pumps, this delay can only occur if the user attempts to start the infusion without first opening the clamp.Under specific conditions, if a treatment that is programmed in epidural mode is started by the user without the user opening the clamp, the pump may not detect an occlusion. this resultant potential delay in therapy may happen, if, and only if, all of the following conditions occur concurrently:a. the clamp is left closed at the “start” of the treatment; andb. the treatment is set at epidural mode; andc. the programmed treatment is set to “bolus only”, i.E., the basal rate=0;this specific combination of conditions may only occur with pumps that have software v11.00 or lower. there is a potential risk of delay in the pain therapy.
  • 조치
    Hospira is advising users to upgrade software on the affected devices. Additionally, Hospira is reminding users to ensure the clamp is open when starting an infusion. This action has been closed-out on 06/09/2016.

Device

Sapphire Multi-Therapy and Sapphire Epidural Pumps with software versions 11.00 and below
  • 모델명 / 제조번호(시리얼번호)
    Sapphire Multi-Therapy and Sapphire Epidural Pumps with software versions 11.00 and belowHospira List Numbers:163113601 and 163123601Q Core Number (on pump): 15031-000-0001 and 15032-000-0001ARTG Number: 201499
  • Manufacturer
    Hospira Pty Limited

Manufacturer

Hospira Pty Limited
  • 제조사 모회사 (2017)
    Pfizer
  • Source
    DHTGA