Baxter IPump Pain Management System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Baxter Healthcare Corp. 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
    33916
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0549-06
  • 사례 시작날짜
    2005-10-27
  • 사례 출판 날짜
    2006-04-26
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2008-11-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Pump, Infusion, Pca - Product Code MEA
  • 원인
    When infusing at flow rates below 0.5 ml/hr, the upstream occlusion alarm of the pumps may not detect the occlusion.
  • 조치
    Baxter sent Urgent Device Correction letters dated 10/27/05 to the direct accounts on the same date via first class mail. The letters informed the accounts of the potential for air to migrate through the silicone-pumping segment of the sets, which may result in air reaching the patient. Baxter recommended that the users of the I-Pump to enable the upstream occlusion sensor of the pump or to use sets containing air-elimination filters if the occlusion sensor is disabled or otherwise not activated. Baxter also recommended that for delivery routes other than epidural and subcutaneous at flow rates below 0.5 mL/hr, infusions should always be performed using a set containing an air eliminating filter (product codes 2L3513, 2L3520, 2L3523, 2L3525, 2L3526 and 2L3527). For users of the APII Pump Baxter recommended that all infusions on the APII, for delivery routes other than epidural and subcutaneous, should be performed using a set containing and air-eliminating filter. Baxter sets not containing an air-eliminating filter (product codes 2L3510 and 2L3511) should not be used with the APII device, and should not be used with the I-Pump when infusing at rates less than 0.5 mL/hr. Any questions were directed to the Center for One Baxter at 1-800-422-9837. Baxter sent a follow-up recall letter to the accounts on 6/21/06, providing them with an Operator's Manual Addendum for the AP II Infusion Pump, with the warning to use only Baxter sets with air-eliminating filters with the AP II pump to avoid undetected air-in-line at low flow rates. The accounts were requested to complete and fax back to Baxter the enclosed reply form, indicating the number of additional copies of the addendum needed.

Device

  • 모델명 / 제조번호(시리얼번호)
    all serial numbers
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide, including Puerto Rico, and internationally to Canada, Chile and China
  • 제품 설명
    Baxter I-Pump Pain Management System infusion pump, product codes 2L3107, 2L3107K and 2L3107R, Baxter Healthcare Corporation, Deerfield, IL 60015
  • Manufacturer

Manufacturer

  • 제조사 주소
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA