Events

Sapphire Administration IV Set AP424 ( Patient Controlled Analgesia IV set for use with the Sapphire infusion pump) 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-2014-RN-01126-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-10-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01126-1
  • 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
    Qcore medical, the manufacturer of sapphire administration iv set ap424 has become aware of an increased incidence in specific batches of sets leaking in the sleeve areas (the adapter that connects between the tube and other components). the infusion set leaks may potentially result in under-dose or allergic reaction (in case the set is leaking and the drug comes into contact with the patient or healthcare professional) or increased risk of infection. the likelihood of harm will depend on the patient’s circumstances, such as the severity of their illness, the healthcare setting and the criticality of the infusion. qcore medical is not aware of any report of injury attributed to this defect.
  • 조치
    Hospira is requesting the users to check the AP24 set for leaks at the start of administration and to follow the instructions for use included with the Administration Sets and with the Sapphire Infusion Pump. New sets, without the defect should be available in mid November. This action has been closed-out on 01/03/2016.

Device

Sapphire Administration IV Set AP424 ( Patient Controlled Analgesia IV set for use with the Sapph...
  • 모델명 / 제조번호(시리얼번호)
    Sapphire Administration IV Set AP424 ( Patient Controlled Analgesia IV set for use with the Sapphire infusion pump)Catalogue Number: 611637201Product reference: 12003-000-0015List Number: 16372A9601Batch Numbers: 0167000814, 0167001414, 0167001514, 0167001914 and 0167002414ARTG Number: 200689
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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