Events

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
    59582
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0142-2012
  • 사례 시작날짜
    2011-09-23
  • 사례 출판 날짜
    2011-10-31
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-04-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103146
  • 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 cvs identified a defective circuit board, which could potentially cause the cdi monitor to not function after a power loss. once power is lost, the monitor will not power up again, even if ac or battery power are restored.
  • 조치
    Terumo Cardiovascular Systems Corporation sent an "URGENT MEDICAL DEVICE CORRECTION" notice dated September 23, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter provides information on what to do in the event of a failure of the device. Additionally, a Customer Response Form was attached to the letter for customers to complete and return. Terumo CVS will schedule the return of affected products for inspection and replacement of defective parts. Contact Terumo CVS Customer Service at 1-800-521-2818 for questions regarding this notice.

Device

CDI 500 Monitor
  • 모델명 / 제조번호(시리얼번호)
    Catalog # 500AVHCT, CDI Blood Parameter Monitoring Systerm 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe; serial numbers 1038,1217,1381,1459,1461, 2515, 3022, 3446, 4043, 4260, 5048-5056, 5065-5077, 5082-5085,5094-5101,5118-5125,5142-5149,5158-5169, 5178, 5179, 5190,5197,5198, 5210-5213,5222-5225,5238-5245, 5250-5253,5274-5277, 5282-5285, 5290-5293, 5298-5305, 5318-5321, 5334-5337, 5341-5344,5354-5356,5370-5374, 5383, 5385, 5386, 5516-5521, and 5537-5541.  Catalog Number 500AHCT, CDI 500 Monitor with Arterial blood parameter module and Hematocrit/Saturation probe. Serial numbers 1258, 1361, 1518, 1571, 1636, 1690,1717,1775,1875,1882, 2026,2292,2413,2459,2832, 2984,3092,3256,3313,3432, 3527, 3633, 3660, 3790, 3825, 4104, 5040-5047, 5057-5064, 5078-5081,5086-5093,5102-5117, 5126-5141, 5150-5157, 5170-5177,5180-5189,5191-5196, 5199-5209,5214-5221, 5226-5237, 5246-5249, 5254-5273, 5278-5281,5286-5289, 5294-5297,5306-5317,5322- 5329, 5345-5348, 5350-5353, 5358-5369, 5375-5382, 5387, 5388, 5500-5515, 5527-5529, 5531,5542,5543,and 5546-5556  Catalog Number 500AV CDI 500 Monitor with Arterial and Venous blood parameter modules. Serial numbers 0033, 0051, 1465, 5330, 5331, 5332, 5333, 5338, 5339, and 5340.  Catalog 500A, CDI 500 Monitor with Arterial blood parameter module. Serial numbers 1560 and 5349.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) and the countries of Canada, Chile, Japan, Philippines, and Thailand.
  • 제품 설명
    CDI Blood Parameter Monitoring System 500 including all Catalog Numbers to include: Catalog # 500AVHCT with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. || Catalog Number 500AHCT, CDI 500 Monitor with Arterial blood parameter module and Hematocrit/Saturation probe. || Catalog Number 500AV CDI 500 Monitor with Arterial and Venous blood parameter modules; and || Catalog 500A, CDI 500 Monitor with Arterial blood parameter module. || Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and /or venous pH, PCO2, K+, or 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 Road, Ann Arbor MI 48103-9586
  • 제조사 모회사 (2017)
    Terumo Corp.
  • Source
    USFDA