Events

Rappel de Device Recall Premixed Dialysate for Hemodialysis

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 NxStage Medical, Inc..

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
    79276
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1132-2018
  • Date de mise en oeuvre de l'événement
    2017-11-10
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161806
  • 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
    Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
  • Cause
    Using different fluid formulations of nxstage pureflow b solution at the same time during treatment may cause patient health risk. the nxstage pureflow b solution is for use with systems that use one premixed dialysate during hemodialysis. the original labeling did not warn against mixing dialysate formulations and did not instruct staff to verify that the fluid is flowing during use.
  • Action
    Customers are advised to : 1. Always make sure when using PureFlow B Solution that fluid is flowing freely from all bags. 2. Recognize that any practice of hanging more than one fluid type at the same time is not an intended use of the NxStage System One" (as it does not monitor fluid composition) and is not a labeled indication of PureFlow B solutions. 3. Please make sure that all users of PureFlow B Solution in your organization and other concerned persons are informed regarding this Field Safety Notice. 4. Complete the enclosed customer reply form and return it to NxStage. Returning the customer reply form promptly will confirm your receipt of this notification and prevent you from receiving repeat notices.

Device

Device Recall Premixed Dialysate for Hemodialysis
  • Modèle / numéro de série
    RFP-400 - M535RFP4000 RFP-400-BB - 00842289101258 RFP-401 M - 535RPF4010 RFP-401-BB - 00842289101265 RFP-402 - M535RFP4020 RFP-403 - M535RFP4030 RFP-404- M535RFP4040 RFP-405 - M535RFP4050 RFP-406 - M535RFP4060 RFP-453 - M535RFP4530 RFP-454 - M535RFP4540 RFP-455 - M535RFP4550 RFP-456 - M535RFP4560
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US nationwide distribution
  • Description du dispositif
    NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
  • Manufacturer
    NxStage Medical, Inc.

Manufacturer

NxStage Medical, Inc.
  • Adresse du fabricant
    NxStage Medical, Inc., 350 Merrimack Street, Lawrence MA 01843-1748
  • Société-mère du fabricant (2017)
    Nxstage Medical Inc
  • Source
    USFDA