Events

Device Recall Baxter System 1000 Delivery System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Baxter Healthcare Renal Div 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
    28375
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0583-04
  • 사례 시작날짜
    2004-02-20
  • 사례 출판 날짜
    2004-07-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-02-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31719
  • 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, Sealed - Product Code FII
  • 원인
    These devices have the potential to overheat in the absence of a ground fault circuit interrupter (gfci). this heater system failure could result in a fire.
  • 조치
    Baxter sent urgent device correction letters dated 2/20/04 to the Hemodialysis Unit Administrators on the same date. The letters informed the accounts of the potential of a heater system failure that under specific conditions could lead to a fire. The letters listed the concurrent conditions that must exist for the potential overheating, and recommended that the following steps be taken to ensure the safety in operating the devices: 1) Plug these machine into GFCI outlets if available, and 2) If GFCI outlets are not available at the facility, the machines must be 'hard-powered off' after dialysis treatments are complete at the end of the day. The machine is had-powered off by placing the main power switch located in the back of the machine into the OFF position. If the facility typically performs a heat clean cycle of machines after treatments are completed, it is imperative that the machines are hard powered off at the completion of the cycle. Any questions were directed to Baxter Instrument Services at 1-800-553-6898, select prompt 3, option 2 and choice 1, Monday through Friday, 8:30 AM to 6:00 PM EST.

Device

Device Recall Baxter System 1000 Delivery System
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers 1001S to 1142S; 50001 to 52109; 01001 to 26231
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The devices were distributed nationwide and internationally to Baxter subsidiaries in Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Denmark, Ecuador, Finland, France, Republic of Georgia, Greece, Guatemala, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Lebanon, Morocco, Malaysia, the Netherlands, Oman, Panama, Preu, Philippines, Poland, Palestine, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Taiwan, Thailand, Tunisia, Turkey and United Kingdom.
  • 제품 설명
    Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as System 1000, AltraTouch 1000, Baxter Tina and Baxter Aurora; Baxter Healthcare Corporation, Deerfield, IL 60015 USA or Baxter Healthcare Corporation, McGaw Park, IL 60085 USA
  • Manufacturer
    Baxter Healthcare Renal Div

Manufacturer

Baxter Healthcare Renal Div
  • 제조사 주소
    Baxter Healthcare Renal Div, 1620 Waukegan Rd Bldg R, Mc Gaw Park IL 60085-6730
  • Source
    USFDA