Device Recall Baxter AP II 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
    34244
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0552-06
  • 사례 시작날짜
    2005-12-21
  • 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
    Delivery of unrequested pca doses of medication due to damaged pca cords, partial sticking of pca button, and fluid ingress into the pump or pca button.
  • 조치
    Baxter sent Urgent Device Correction letters dated 12/21/05 to the direct accounts on the same date via first class mail. The letters informed the accounts of the potential for unrequested PCA doses due to an electrical short in the PCA circuit simulating repeated pressing of the PCA button. The unrequested bolus doses will not exceed the programmed prescription limits. The letter listed three conditions identified that can produce an electrical short in the PCA circuit and simulate repeated pressing of the PCA button: * Damaged PCA cord or button, * Partial sticking of the PCA button, and * Fluid ingress into the pump or PCA button. Information was provided to reduce the potential for these conditions from occurring during use of the pumps. Customers were asked to ensure that prior to or after each use the PCA cord is intact and has no cuts or missing insulation, and that the pump connector and the button are securely attached to the cord. They were also asked to immediately take the pump and PCA cord out of service for repair if the pump displays 'Release the PCA Button' and the PCA button is not being intentionally pressed, as there may be a mechanical or electronic fault in the PCA button. They were also asked two avoid getting liquids inside the pump as permanent damage may result. Baxter recommended that the institutions implement a regular preventative maintenance program and periodic replacement of the PCA cords based on their own specific usage patterns. 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 and the PCA II Infusion Pump, with the warnings to ensure that prior to or after each use that the PCA cord is intact and has no cuts or missing insulation, and that the pump connector and the button are securely attached to the cord; to avoid getting liquids inside the pump; and

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, China, Hong Kong, Korea, Kuwait, Malaysia, Taiwan and Saudi Arabia
  • 제품 설명
    AP II Pain Management System infusion pump, product codes 2L3105, 2L3105K, 2L3105R, 2L3105T and 2L3105W; Baxter Healthcare Corporation, Deerfield, IL 60015
  • Manufacturer

Manufacturer

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