Events

Baxter Healthcare HomeChoice Pro APD System 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
    66737
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1292-2015
  • 사례 시작날짜
    2013-10-16
  • 사례 출판 날짜
    2015-03-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-07-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123221
  • 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
    The occluder in affected devices 1) may have sharp edges that could cut the pneumatic tubing that connects the occluder blade to the manifold causing an unrecoverable system error, and/or 2) blade may separate from the back plate and cause slow / no flow alarm requiring therapy termination.
  • 조치
    An Urgent Device Correction letter dated 10/16/13 was mailed to dialysis centers and medical facilities. A similar Urgent Device Correction letter dated 10/31/13 was mailed to dialysis home patients. The letters requested for customers to examine their devices to determine if the devices are being recalled. If the devices are on the attached list of recalled devices, the customer is to contact Baxter Technical Services at 1-800-553-6898 (7 days a week, 24 hours a day) to arrange for a swap cycler. The letter further requests that customers complete the attached Customer Reply Form and return it to Baxter by fax or e-mail.

Device

Baxter Healthcare HomeChoice Pro APD System
  • 모델명 / 제조번호(시리얼번호)
    Product Code: 5C8310;  Serial Numbers: 80415, 680416, 680418, 680420, 680421, 680422, 680424, 680426, 680427, 680428, 680429, 680430, 680438, 680439, 680440, 680441, 680444, 680445, 680448, 680449, 680452, 680453, 680454, 680455, 680456, 680457, 680459, 680460, 680461, 680462, 680463, 680465, 680467, 680467, 680469, 680470, 680472, 680473, 680475, 680476, 680477, 680478, 680480, 680481, 680482, 680463, 680484, 680485, 680486, 680489, 680490, 680491, 680494, 680495, 680496, 680498, 680499, 680500, 680501, 680502, 680503, 680504, 680505, 680506, 680507, 680508, 680509, 680510, 680516, 680517, 680519, 680520, 680521, 680522, 680524, 680525, 680526, 680527, 680527, 680528, 680529, 680530, 680532, 680533, 680534, 680536, 680537, 680538, 680539, 680541, 680542, 680543, 680547, 680552, 680553, 680544, 680555, 680561, 680562, 680566, 680567, 680585, 680586, 680587, 680588, 680589, 680590, 680591, 680593, 680594, 680595, 680596, 680597, 680598, 680599, 680600, 680601, 680602, 680603, 680604, 680605, 680606, 680607, 680608, 680609, 680611, 680612, 680613, 680614, 680615, 680616, 680617, 680618, 680619, 680620, 680621, 680622, 680623, 680624, 680625, 680626, 680627, 680628, 680629, 680630, 680631, 680632, 680633, 680634
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-US (nationwide) including the states of AK, AR, AZ, CA, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MO, NC, NJ, NV, NY, OH, PA, SC, TN, TX, UT, VA, VT, WA, and WI, and the countries of Australia, Canada, and Mexico.
  • 제품 설명
    The HomeChoice Pro APD System is a peritoneal dialysis system. || The HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchange in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.
  • 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