Events

Baxter AMIA APD 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
    70194
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1245-2015
  • 사례 시작날짜
    2014-04-03
  • 사례 출판 날짜
    2015-03-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-07-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132475
  • 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
    System, dialysate delivery, recirculating - Product Code FIK
  • 원인
    Additional warning in the amia apd system labeling for patients vulnerable to unintended increased intraperitoneal volume (iipv), also known as overfill. the patients include neonates, infants, small children, and any patient with significant heart and/or lung disease.
  • 조치
    Baxter sent IMPORTANT PRODUCT INFORMATION letters dated April 3, 2014 to all peritoneal dialysis healthcare providers of record. The letters advised healthcare providers of the potential to develop Increased Intraperitoneal Volume (IIPV) and instructed the healthcare providers to complete and return the attached Customer Reply Form. Healthcare providers with clinical questions can contact Baxter's Renal Division Clinical Helpline at 888-736-2543, option 2, 8:00 AM - 5:00 PM CT. Healthcare providers with general questions can contact The Center for One Baxter by telephone at 800-422-9837, Monday - Friday, 8:00 AM - 5:00 PM CT. Additionally, an IMPORTANT PRODUCT INFORMATION letters dated April 8, 2014 were sent to all peritoneal dialysis patients of record. The letters advised patients of the potential to develop Increased Intraperitoneal Volume (IIPV) and instructed the patients to complete and return the attached Home Patient Reply Form. Patients with questions about the letter can contact The Center for One Baxter by telephone at 800-422-9837, Monday - Friday, 8:00 AM - 5:00 PM CT.

Device

Baxter AMIA APD System
  • 모델명 / 제조번호(시리얼번호)
    Product Code: 5C9310
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US: Nationwide in the states of (GA, MA, NC, NY, PA, WA)
  • 제품 설명
    AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • 제조사 주소
    Baxter Healthcare Corp., 1 Baxter Pkwy, Deerfield IL 60015-4625
  • 제조사 모회사 (2017)
    Baxter International
  • Source
    USFDA