Events

Rappel de Device Recall CDI Blood Parameter Monitoring System 500

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Terumo Cardiovascular Systems Corporation.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    73533
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1250-2016
  • Date de mise en oeuvre de l'événement
    2016-03-14
  • Date de publication de l'événement
    2016-03-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-03-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144421
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Monitor, blood-gas, on-line, cardiopulmonary bypass - Product Code DRY
  • Cause
    Specific cdi¿ blood parameter monitoring system 500 devices are being voluntarily recalled because the bpm sensor head assemblys thermistor, which provides the blood temperature value that results in accurate display values on the monitor, does not meet specification. this may cause inaccurate temperature measurement and inaccurate analyte display values on the cdi system 500 monitor. terumo cardiovascular systems (terumo cvs) received complaints of inaccurate temperature measurements for specific devices distributed since november 5, 2015. these include both new production devices and recently serviced devices. potential hazard there have been no reported illnesses or injuries as a result of this issue. a user who is not aware that the cdi system 500 is displaying inaccurate temperature values may not manage patient temperature appropriately. using inaccurate information to manage warming and cooling strategies for a procedure could result in prolonged time on bypass. it could also lead to unnecessarily aggressive temperature management, resulting in excessive hyper or hypothermia, with potential neurologic and organ dysfunction, or increased blood component damage. inaccurate temperature measurement could also cause inaccurate measurements of other bpm values including potassium (k+), po2, pco2, and ph. the greater the temperature inaccuracy, the greater the degree of inaccuracy of these other bpm values due to the dependence of their algorithms on temperature for the calculations. inaccurate measurement of these values could result in inappropriate patient management strategies being employed to address them with the potential to result in moderate patient injury.
  • Action
    Terumo sent an " URGENT MEDICAL DEVICE RECALL" notification dated March 14, 2016, to all affected customers via mail. The letter identified the product the problem and the action needed to be taken by the customer. The Recall Notification has instructions for responding to the formal recall notification. If you have questions, contact Terumo CVS Customer Service: 800.521.2818 Customer Service Hours: Monday  Friday 8 a.m.  6 p.m. ET

Device

Device Recall CDI Blood Parameter Monitoring System 500
  • Modèle / numéro de série
    CDI 500 MONITOR WITH ART/HS  (500AHCT item number 137613) SN #'s: 1190 1310 1346 1594 1647 1687 1693 1706 1769 1866 2028 2220 2242 2294 2311 2394 2460 2485 2506 2519 2644 2729 2776 2780 2821 2827 2858 2898 2900 3002 3092 3163 3184 3325 3513 3805 3808 3818 3823 3842 4061 4102 4109 5173 5264 5806 8003 8006 8007 8008 8009 8010 8011 8012 8013 8016 8018 8020 8026 8031 8034 8035 8040 8056 8060 500AHCT MTR - CON LOANER  (500AHCTCL item number 411150) SN #'s: 1035 1060 1178 1198 1199 1228 1280 1325 1364 1535 1540 1545 1553 1557 1615 1689 1695 1743 1759 1850 1862 1942 1949 1988 2014 2147 2336 2359 2360 2557 2563 2609 3097 3337 3431 3433 3527 4059 4324 4327 5609 5698 5700 5701 5809 5820 5889 5894 5945 5991 7028 7029 7030 7034 7038 7061 500AHCT MONITOR - LOANER  (500AHCTL item number 418538) SN #'s: 1283 2209 5546 CDI 500 MONITOR WITH ART/VEN  (500AV item number 137621) SN #'s: 3132 6004 CDI 500 MONITOR W/ ART/VEN/HS  (500AVHCT item number 137630) SN #'s: 1304 1405 1905 2105 2224 2495 2580 2633 2867 3332 3404 4224 5076 5096 8000 8002 8023 500AVHCT MTR - CON LOANER  (500AVHCTCL item number 411168) SN #'s: 1036 1043 1046 1149 1151 1152 1264 1353 1354 1381 1389 1393 1624 1954 2074 2126 6016 6041 6042 6046 500AVHCT MONITOR-LOANER  (500AVHCTL item number 372200) SN #'s: 1015 1038 1466 2035 7081 500AVHCT MONITOR - TRIAL  (500AVHCTTK item number 476543) SN #'s: 1953 3425 500AV MONITOR - LOANER  (500AVL item number 418520) SN #: 2023  Outside US. BPM SENSOR HEAD ASSY CDI 500  item number 145891 SN#'s: B019781  B019782  B019783  B019784  B019790  B019791  B019792  B019793  B019794  B019795  B019796  B019797  B019798  B019799  B019800  B019802  B019803  B019804  B019805  B019806  B019807  B019808  B019809  B019810  B019811  B019812  B019813  B019814  B019815  B019816  B019848  B019849  B019850  B019851  B019869  B019870  B019871  B019872  B019876  B019877  B019878  B019879  B019880  B019881  B019882  B019883  B019884  B019885  B019886  B019887  B019888  B019889  B019890  B019901  B019917  B019918  B019919  B019920  B019921  B019937  B019938  B019939  B019940  B019941  B019947  B019948  B019949  B019950  B019951  B019957  B019958  B019959  B019960  B019961  B019962  B019963  B019965  B019966  B019967  B019968  B019969  B019970  B019971  B019978  B019979  B019980  B019981  B019982  B019983  B019984  B019985  B019986  B019987  B019988  B019989  B019990  B019991  B019997  B019998  B019999  B020000  B020001  B020003  B020005  B020007  B020008  B020010  B020013  B020014  B020015  B020020  B020021  B020022  B020023  B020024  B020025   BPM SENSOR HEAD ASSY ROHS  item number 858828 SN #'s: B021130  B021131  B021132  B021133  B021134  B021139  B021141  B021142  B021144  B021145  B021146  B021147  B021148  B021149  B021199  B021201  B021202  B021211  B021213  B021215  B021219  B021220  B021221  B021234  B021235  B021236  B021237  B021238  B021239  B021254  B021259  B021260  B021261  B021262  B021264  B021265  B021266  B021267  B021268  B021270   CDI 500 MONITOR WITH ART/HS  (500AHCT item number 137613) SN #'s: 1899 1948 2473 3030 3078 3230 3339 3587 3623 8004 8005 8014 8015 8017 8019 8021 8025 8027 8029 8030 8032 8033 8035 8035 8036 8038 8055 8056 8056 8059  CDI 500 MONITOR W/ ART/VEN/HS  (500AVHCT item number 137630) SN #'s: 1271 1902 2515 2784 3544 4018 4342 5147 5148 5303 8001 8022 8024 8037 8039 8046 8063 8064 8065 8066 8067
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - Nationwide Distribution and to the countries of : Australia, Belgium, Canada, Japan , Singapore and United Arab Emirates.
  • Description du dispositif
    CDI Blood Parameter Monitoring System 500 || Cardiopulmonary bypass on-line blood gas monitor || Product Usage: || The CDL System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37 C. For documentation purposes, the system 500s integral printer provides a hard copy of displayed parameters.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Adresse du fabricant
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Rd, Ann Arbor MI 48103-9586
  • Société-mère du fabricant (2017)
    Terumo Corp.
  • Source
    USFDA