Events

Colied-Tube INFUSOR System 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Baxter Healthcare 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-00448-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-04-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00448-1
  • 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
    Baxter is issuing a safety alert to notify users of factors that can contribute to over-infusion. when multiple factors are combined infusion rates can be in excess of 30% greater than the nominal flow rate. additionally, end users are being notified of a correction to the instructions for use. recent review of flow rate testing by baxter has identified that the nominal flow rate is achieved when the elastomeric reservoir is positioned 15-20cm below the distal luer lock.
  • 조치
    Baxter is reiterating the factors that may impact flow rate as described in the instructions for use (IFU). Baxter is also notifying end users of an amendment to the instructions for with regard to the optimal Elastomeric Reservoir position. End users are advised that nominal flow is achieved when the Elastomeric Reservoir is positioned 15-20cm below the distal luer lock and not when positioned at the same height as stated in the IFU.

Device

Colied-Tube INFUSOR System
  • 모델명 / 제조번호(시리얼번호)
    Colied-Tube INFUSOR SystemProduct Codes:2C1071KJP - Single Day Infusor 2 ml/h System2C1071KJ - Single Day Infusor 2 ml/h System2C1073KJP - Half Day Infusor SV 5 ml/h System2C1075KJP - Two Day Infusor 2 ml/h System2C1080KJP - Multi Day Infusor 0.5 ml/h System2C1082KJP - Seven Day Infusor 0.5 ml/h System2C1082KJ - Seven Day Infusor 0.5 ml/h SystemARTG Number: 46196
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd