Events

Device Recall Baxter SPS 550 Hemodialysis Machine 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
    25607
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0660-03
  • 사례 시작날짜
    2003-02-20
  • 사례 출판 날짜
    2003-03-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2006-03-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26144
  • 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, Single Patient - Product Code FKP
  • 원인
    Excess or insufficient ultrafiltration may occur during manual control of ultrafiltration via adjustment of transmembrane pressure (tmp).
  • 조치
    Baxter sent Safety Alert letters dated 2/20/03 to the end users, informing them of the possibility of either excess or insufficient ultrafiltration when the operator manually controls ultrafiltration via adjustment of transmembrane pressure. The accounts were informed that turning off the UF controller during fault codes FL-04, FL-07 and FL-08 may affect the ability to safely perform manual ultrafiltration, and that treatment should be discontinued if those three fault codes are displayed. Changes to the instructions for use are in process and will be sent to the end users when completed. Additionally, the Baxter 1550 has a side panel that contains a 16-digit display. Currently, during all ultrafiltration system fault modes the display indicates 'Manual UF Control'. To avoid operator confusion, new software is being developed that will provide a display of 'Discontinue TX' when a FL-04, FL-07 or FL-08 fault code occurs. The SPS 550 does not have the side panel display and does not require the software upgrade.

Device

Device Recall Baxter SPS 550 Hemodialysis Machine
  • 모델명 / 제조번호(시리얼번호)
    catalog numbers 5M1309, 5M1309R, 5M1310, 5M1310R, 5M5506, 5M5506R, 5M5507, 5M5507R, 5M5516, 5M5516R, 5M5518, 5M5518R, 5M5533, 5M5536, FM4649, FM4654, FM4714, FM4796R, FM4797;all serial numbers
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide and internationally to Algeria, AMerican Samoa, Argentina, Aruba, Australia, Barbados, Belgium, Bolivia, Brazil, Brunei, Burma, Canada, Chile, China, Colombia, Croatia, Cyprus, Dominican Republic, Ecuador, Egypt, El Salvador, Yugoslavia, Germany, Ghana, Guam, Guatemala, Honduras, Hong Kong, Hungary, INdia, Indonesia, Israel, Italy, Jamaica, Jordan, Lebanon, Malaysia, Mexico, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Romania, Russia, South Korea, Singapore, Slovakia, Slovenia, South Africa, Spain, St. Maarten, Taiwan, Thailand, Tobago, Trinidad, Turkey, United Kingdom, Uruguay, Venezuela and Vietnam.
  • 제품 설명
    Baxter SPS 550 Single Patient System Hemodialysis Machine; Baxter Healthcare Corporation, Renal Division, 1425 Lake Cook Road, Deerfield, IL 60015
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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