Prismaflex 5.10 US 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Baxter Healthcare Corporation 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
    79965
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1923-2018
  • 사례 시작날짜
    2018-04-24
  • 사례 상황
    Open, Classified
  • 사례 국가
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
  • 원인
    Baxter healthcare will be installing new firmware on all prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics. the failure mode may result in a voltage out of range malfunction alarm, which causes the device to enter a safe state and become inoperable until it is serviced. baxter will be releasing new firmware that will prevent the malfunction from occurring.
  • 조치
    The firm, Baxter, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated 4/24/2018 to its customers. The letter explained the reason for the recall and provided the following direction: "Operators may continue to safely use Prismaflex control units that have not exhibited the Voltage Out of Range malfunction alarm. A local Baxter service representative will contact your facility to determine the correction plan and schedule the firmware upgrade. Your facility will be receiving this firmware upgrade from Baxter at no charge. f you purchased this product directly from Baxter, complete the enclosed Baxter Customer Reply Form and return it to Baxter by faxing it to 224-270-5457 or scanning and e-mailing it to fca@baxter.com, even if you do not have any inventory. Returning the customer reply form promptly will confirm your receipt of this notification and prevent you from receiving repeat notices. If you purchased this product from a distributor, please note that the Baxter customer reply form is not applicable. If a reply form is provided by your distributor or wholesaler, please return it to the supplier according to their instructions. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers of this Urgent Medical Device Correction in accordance with your customary procedures." If you have any questions, call Baxter Corporate Product Surveillance at 800-437-5176 between the hours of 8:00 am and 5:00 pm Central Time, Monday through Friday or Email Baxter at: corporate_product_complaints_round_lake@baxter.com.

Device

  • 모델명 / 제조번호(시리얼번호)
    All Lots and Serial Numbers
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: United States (including Puerto Rico), and countries of: Canada, Australia, New Zealand, China, Bangladesh, Japan, Malaysia, Myanmar, Sri Lanka, India, Singapore, Vietnam, Hong Kong, Korea, Taiwan, Indonesia, Bruni, Philippines, Thailand, Argentina, Chile, Costa Rica, Dominican Republic, Haiti, Barbados, Bermuda, Venezuela, Cuba, Mexico, Colombia, Brazil and EMEA.
  • 제품 설명
    Prismaflex 5.10 US, Product Code 113081 || Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated. " Continuous Renal Replacement Therapy (CRRT) in conjunction with the MARS system to conduct MARS treatments for patients weighing 20 kilograms or more. All treatments administered via the Prismaflex control unit must be prescribed by a physician.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Baxter Healthcare Corporation, 1 Baxter Pkwy, Deerfield IL 60015-4625
  • 제조사 모회사 (2017)
  • Source
    USFDA