Events

Device Recall CDI 500 Monitor 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Terumo Cardiovascular Systems 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
    60480
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1733-2013
  • 사례 시작날짜
    2013-02-27
  • 사례 출판 날짜
    2013-07-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-02-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109153
  • 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
    Monitor, blood-gas, on-line, cardiopulmonary bypass - Product Code DRY
  • 원인
    Terumo discovered through its own testing that cdi 500 blood parameter monitoring system software contains inaccuracies associated with a software algorithm, and a software update has been developed to address this issue and a premarket notification (k130425) has been submitted to the agency. once clearance is received for this premarket notification from the us fda, terumo cvs will implement the.
  • 조치
    On 2/27/13, all consignees will receive a recall notification letter via Federal Express. Terumo CVS will correct all affected CDl Monitors. Correction to the devices will be completed concurrently with BPM replacements related to Z-2185/2189-11 RES 57194. Terumo continues to manufacture and ship devices affected by this recall. The long term corrective actions are associated with Recall# Z-2185/2189-11 RES 57194. As committed previously, we will re-notify all customers once we are ready to implement the fix for the BPM in the field. All units produced prior to the change in manufacturing will be included in the scope of this correction. Terumo continues to manufacturer units affected by this correction. All units returned for this correction will be tagged with a service traveler to indicate reason for correction and units will be properly segregated to prevent unintended re-shipment.

Device

Device Recall CDI 500 Monitor
  • 모델명 / 제조번호(시리얼번호)
    Catalog number: 500A* and serial numbers: 1211,1559-1563,1663-1666,1722-1727,1754-1758, 1776, 1795, 1951, 1952, 2016, 2112, 2117, 2190, 2246, 2273, 2274, 2322, 2355, 2356,2389-2391, 2393, 2394, 2397, 2634, 2700, 2801, 2804, 2860, 2890, 2891, 3011-3013, 3125, 3146, 3263, 3289, 3410, 3417, 3480, 3629-3631, 3646-3648, 3661, and 5349.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, 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, SC, SD, TN, TX, UT, VA, WA, WI, and WV and the countries of Jordan, CANADA, AUSTRALIA, Japan ,Hong Kong ,UNITED ARAB EMIRATES (UAE), BELGIUM, South Korea, Malaysia, Mexico, Philippines, Singapore, Taiwan, and Thailand.
  • 제품 설명
    CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module. || Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • 제조사 주소
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Rd, Ann Arbor MI 48103-9586
  • 제조사 모회사 (2017)
    Terumo Corp.
  • Source
    USFDA