Events

Rappel de Sigma Spectrum Infusion Pump component (LCD screen)

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 Baxter Healthcare Corp..

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
    66392
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0189-2014
  • Date de publication de l'événement
    2013-11-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-11-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122243
  • 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
    Pump, infusion - Product Code FRN
  • Cause
    Baxter healthcare corporation is recalling the lcd display screen on the sigma spectrum infusion pump with master drug library for not meeting standards for withstanding an electrostatic discharge.
  • Action
    Baxter Healthcare Corporation sent an Urgent Product Recall letter dated September 24, 2013 to all affected customers via first class mail. The letter identified the affected product, problem and actions to be taken. Customers were instructed to locate the affected product, remove them from use and acknowledge your receipt of the recall notification by completing the provided Customer Reply Form and fax to 224-270-5467. Customers were asked to contact Baxter Healthcare Medina at 800-356-3454 (choose option 1) Monday through Friday during the hourse of 7:00 am and 7:00 pm Eastern Time to order replacement device(s). For technical questions contact Baxter Healthcare Medina at 800-356-3454, (choose option1) and for clinical questions contact Medical Information Services at Baxter 800-933-0303.

Device

Sigma Spectrum Infusion Pump component (LCD screen)
  • Modèle / numéro de série
    Product Code: 35700BAX & 35700ABB; Serial Numbers: 433713, 435563, 704056, 707290, 715315, 724216, 740127, 752318, 752447, 753675, 754947, 759766, 765934, 770034, 772017, 773470, 776507, 781016, 781969, 783352, 783454, 787567, 789720, 791225, 794828, 794990, 797185, 804798, 808393, 808764, 810971, 812076, 818718, 821213, 824067, 824198, 839143, 850028, 850577, 852007, 852431, 855450, 860201, 864799, 876765, 877548, 877944, 878637, 879810, 879886, 880022, 884707, 884778, 885565, 889416, 889814, 890949, 890987, 894957, 895413, 896662, 896912, 897576, 900401, 904778, 913511, 915035, 915981, 916173, 916948, 919159, 921162, 921937, 922515, 923861, 945583, 953011, 953360, 953995, 955881, 959847, 967694, 978892, 981692, 986022, 997333, 998512, 1002325, 1018432, 1018436, 1018737
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide in the states of: AR, AZ, CA, CO, CT, FL, HI, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NM, NY, OH, OK, OR, PA, TN, UT, VA, WA and WV and the country Canada.
  • Description du dispositif
    SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen, 55074-2 revision B) || Product Usage: Intended to be used as a visual aid during the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Adresse du fabricant
    Baxter Healthcare Corp., 1 Baxter Pkwy, Deerfield IL 60015-4625
  • Société-mère du fabricant (2017)
    Baxter International
  • Source
    USFDA