Events

Baxter 6060E & Sabratek 6060 Epidural Infusion Pumps 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
    33032
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1592-05
  • 사례 시작날짜
    2005-08-17
  • 사례 출판 날짜
    2005-09-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2007-06-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41229
  • 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 - Product Code FRN
  • 원인
    Potential overinfusion in the auto-ramp mode with software versions 3.00 or higher.
  • 조치
    Baxter sent the 8/17/05 Urgent Product Recall letter to all Baxter 6060E Infusion Pump customers to inform them of a software anomaly present in software versions 3.00 and higher, which allows the pump to overinfuse in the Auto-Ramp mode. The end users were also informed that these epidural pumps, identified by the yellow housing, can no longer be supported due to a lack of availability of spare parts and Baxter is unable to replace the software with an alternate version. As a result, Baxter requested the accounts to remove the pumps from service and return them to Baxter. The accounts were requested to call Baxter''s Medication Delivery Services at 1-800-843-7867 to arrange for the return of the units and replacement with 6060 Multi-Therapy Infusion Pumps.

Device

Baxter 6060E & Sabratek 6060 Epidural Infusion Pumps
  • 모델명 / 제조번호(시리얼번호)
    product codes 2L9351, 2L9351P, 2L9351R, 606000-40E and 606000-40EL: all serial numbers
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide including Puerto Rico, and intenationally to Canada, China, Belgium, Hong Kong and Saudi Arabia
  • 제품 설명
    Epidural Infusion Pumps sold under the following labels; || a) Baxter 6060E Epidural Infusion Pump, product code 2L9351, 2L9351P and 2L9351R; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60013 USA, made in Singapore || b) Sabratek 6060 Epidural Pain Management Pump, product codes 606000-40E and 606000-40EL; Manufactured by Sabratek Corp., Skokie, IL 60076, which was purchased by Baxter Healthcare Corp., Deerfield, IL in January 2000.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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