Events

Rappel de Device Recall Prismaflex

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 Gambro Renal Products, Incorporated.

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
    58208
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1901-2011
  • Date de mise en oeuvre de l'événement
    2011-03-14
  • Date de publication de l'événement
    2011-04-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-09-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98675
  • 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
    Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
  • Cause
    Prismaflex touch screen may become unresponsive during continuous renal replacement therapy procedure.
  • Action
    The firm, GAMBRO Renal Products, sent an "URGENT - MEDICAL DEVICE RECALL" letter dated March 14, 2011 to all customers. The letter described the product, problem and actions to be taken. The customers were provided with response procedures to use if the frozen screen problem occurs while using the product. The customers were instructed to closely monitor the return line for potential air and/or clots in the circuit; review the instructions provided in the attached copy of Chapter 5: Troubleshooting, "Softkeys won't work." of the Prismaflex Operators Manual in conjunction with the attached Troubleshooting Checklist; be aware if performing Manual Termination with Blood Return, air detection is not provided, and complete and return the Customer Reply Form via fax to: Regulatory Affairs at 1-866-447-4471 or 303-222-6916, or by email to: GRPRegulatory.Affairs@us.gambro.com. If you have any questions or concerns, please contact for Clinical questions: ICON 800-554-1312 (available 24/7) or your local Gambro Representative; for Technical questions: Gambro Customer Support 800-525-2623, option 2 (Available 6:00am to 5:30pm MT, Monday thru Friday).

Device

Device Recall Prismaflex
  • Modèle / numéro de série
    All units with Version 3.20 software.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution.
  • Description du dispositif
    Prismaflex System, Catalog Number 107493, || Indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload.
  • Manufacturer
    Gambro Renal Products, Incorporated

Manufacturer

Gambro Renal Products, Incorporated
  • Adresse du fabricant
    Gambro Renal Products, Incorporated, 14143 Denver West Pkwy, Lakewood CO 80401-3266
  • Société-mère du fabricant (2017)
    Baxter International
  • Source
    USFDA