Events

HomeChoice/HomeChoice PRO 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
    69468
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0939-2015
  • 사례 시작날짜
    2014-10-06
  • 사례 출판 날짜
    2015-01-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-03-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130726
  • 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, peritoneal, automatic delivery - Product Code FKX
  • 원인
    There are additional and updated warning and cautions that are not in the patient at-home guide for homechoice automated pd systems and homechoice pro automated pd systems.
  • 조치
    The firm, Baxter, sent an "IMPORTANT PRODUCT INFORMATION" letter dated October 6, 2014 to all peritoneal dialysis provider direct accounts. Baxter also sent an "IMPORTANT PRODUCT INFORMATION" letter dated October 9, 2014 to all peritoneal dialysis patient direct accounts The letters described the product, problem and actions to be taken. The letters included instructions for the recipients to complete the attached Customer Reply Form and to return it to Baxter via scanned e-mail to: fca@baxter.com or fax : 224-270-5457. In addition, the letter to patients instructed them to contact their healthcare provider to discuss this issue. Customers with clinical questions should contact Baxter's Renal Division Clinic Helpline at 888-736-2573, option 2 (8:00 AM - 5:00 PM CST). Adverse reaction or quality problems experienced with the use of these product can be reported by contacting Baxter Product Surveillance at 800-437-5176 (Monday - Friday, 8:00 AM - 5:30 PM CST) or e-mail to corporate_product_complaints_round_lake@baxter.com. Customers with general questions about the letter should contact The Center for One Baxter at 800-422-9837 (Monday - Friday, 8:00 AM - 5:00 PM CST).

Device

HomeChoice/HomeChoice PRO
  • 모델명 / 제조번호(시리얼번호)
    Product Codes: 5C4471(R), 5C8310(R); Serial Numbers: All serial numbers
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) Including states of: AK, AL, AR, AZ, CA, CO, CT, DE, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and District of Columbia; and countries of: Algeria, Argentina, Aruba, Australia, Austria, Bahamas, Bahrain, Barbados, Belarus, Belgium, Bosnia, Brazil, Bulgaria, Cayman Islands, Chile, Colombia, Croatia, Cuba, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kuwait, Lebanon, Macedonia, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Poland, Portugal, Quatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
  • 제품 설명
    HomeChoice Automated PD system and HomeChoice Pro Automated PD system Baxter's || HomeChoice and HomeChoice Pro APD systems are designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients. Their Fill volumes can range from 60 mL to 3000 mL. The HomeChoice and HomeChoice Pro APD systems are intended to be operated by: 1) Home patients whose physicians have prescribed this system. Patients, or their caregivers, must have received adequate training to use the system. 2) Clinicians who are using the system for patients under their care and under a prescription. Clinicians must have received adequate training to use the system. Since drain and volume requirements vary among patients, both the HomeChoice and HomeChoice Pro APD systems have a choice of modes, either Standard Fill Mode (Standard Mode) or Low Fill Mode. The dialysis center selects the Fill mode for the patient before therapy begins. The HomeChoice APD system and HomeChoice Pro APD system are the same in operation, except for the Pro Card and modem features that are only available with the HomeChoice Pro APD system. The Pro Card feature stores prescription and therapy data. The data can be transferred between your cycler and your clinician. The two systems use the same disposable sets and solutions. They perform the same therapies the same way.
  • 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