Events

SPECTRUM Pump 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
    69122
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2738-2014
  • 사례 시작날짜
    2014-09-03
  • 사례 출판 날짜
    2014-10-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-03-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129683
  • 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
    One service technician may not have correctly serviced specific sigma spectrum infusion pumps according to established procedures during the time period of 5/5/2014 through 6/3/2014.
  • 조치
    Initial notification was initiated via telephone call by the Baxter Medina Service Center on 8/28/14 to all affected Sigma SPECTRUM Infusion Pump consignees. URGENT DEVICE CORRECTION Letters (dated 9/03/2014) were sent to the consignees via USPS first class mail on 9/03/14 formally informing them of the recall. The letters identified the affected product, the description of the issue, the hazard involved, as well as, the actions to be taken by customer. Customers are being instructed to immediately remove the pump from use and return the pump to Baxter for inspection. The firm will provide replacements. Customers are to contact Baxter Healthcare Medina at 800-356-3454 for technical questions regarding the letter.

Device

SPECTRUM Pump
  • 모델명 / 제조번호(시리얼번호)
    Software Versions 5.02.06, 6.02.06, and 6.02.11; Affected Serial Numbers: 712090, 723687, 723842, 724966, 725820, 735977, 751130, 752124, 755174, 768538, 771990, 774743, 781406, 783736, 784698, 794466, 805797, 808901, 809113, 812462, 815932, 842120, 857926, 858672, 862085, 863721, 865630, 873459, 889597, 890260, 903748, 912619, 920574, 920589, 956346, 957394, 965402, 966684, 976931, 977550, 978361, 983979, 984066, 984129, 984475, 985946, 987538, 993445, 995291, 996014, 996389, 1013037, 1004377, 1014565, 1014962, 967887, 950671, and 938428.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA and Canada.
  • 제품 설명
    SPECTRUM Pump, Model No. 35700BAX. || Intended to be used for the controlled administration of intravenous fluids.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • 제조사 주소
    Baxter Healthcare Corp., 25212 W. Illinois Route 120, Round Lake IL 60073-9799
  • 제조사 모회사 (2017)
    Baxter International
  • Source
    USFDA