Events

SIGMA Spectrum INFUSION PUMP with Master Drug Library 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
    75311
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0671-2017
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-06-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150047
  • 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
    A correction was issued for the sigma spectrum infusion pump with master drug library in order to replace speakers installed in pumps or included in spare part rear case assemblies that have an increased potential to fail prematurely.
  • 조치
    Baxter sent an Urgent Medical Device Correction letter dated September 28, 2016, to all affected customers. On 10/27/2016, Baxter Healthcare sent a f/u UMDC Letter (dated 10/27/2016) to customers. The f/u letter contains the device correction plan which states that Baxter will be replacing at no charge the rear case assembly on all affected Sigma Spectrum Infusion Pumps, as well as affected stand-alone rear case assemblies shipped to customers as spare parts. For questions, please contact your Baxter sales representative, or Baxter Healthcare Medina at 800-356-3454 (choose option 1) Monday through Friday, between 7:00 am and 7:00 pm ET.

Device

SIGMA Spectrum INFUSION PUMP with Master Drug Library
  • 모델명 / 제조번호(시리얼번호)
    Contact CDRH for list of affected serial numbers (15,517).
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution, Puerto Rico and Canada
  • 제품 설명
    Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum Infusion Pump, Product Code 35700BAX2, Unique Device Identifier GTIN 00085412091570, Rx ONLY -- Baxter Healthcare Corporation, Medina, NY 14103 --- NOTE: The speakers are a part of the rear case assembly located in the back of the infusion pump. The speaker is intended to generate audible tones during each keystroke, and during alarm conditions. However, some speakers have a variation in their internal wiring that increases the potential for the speaker to fail prematurely. Spectrum Infusion Pumps with non-functional speakers will continue to display visual alarm indications, and will otherwise continue to operate as intended.
  • 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