Events

Rappel de Device Recall RenalSoft

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 Renal Div.

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
    45856
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0527-2008
  • Date de mise en oeuvre de l'événement
    2007-11-14
  • Date de publication de l'événement
    2008-01-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-02-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66269
  • 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
    Semi-Automatic Peritoneal Dialysate Delivery System - Product Code KPF
  • Cause
    Pre-treatment/post-treatment report errors: 1) the heparin bolus value is displayed on pre and post treatment reports for patients with "no heparin" orders (renalsoft v2.0, renal software suite v.3.0 and v.3.1), and 2) withheld medications are incorrectly displayed as administered on the pre-treatment report (renalsoft v.2.0 only).
  • Action
    Baxter Healthcare Corporation sent an Urgent Device Correction letter, dated 11/14/07, to all of the affected customers, informing them of the Heparin Bolus and the Withheld Medication issues and provided them with interim mitigation instructions that they should implement while waiting for a software correction. A Baxter representative will contact the customer to schedule the software update when the upgraded software is released. Customers were requested to complete and return the enclosed Customer Reply Form, indicating that they have disseminated the information to their staff, and indicating if they still have RenalSoft software and require an upgrade. Any questions were directed to Baxter Global Technical Services at 1-800-553-6898, option 4. A follow-up letter dated 3/6/08 was sent to the consignees on the same date, informing them that the upgraded RenalSoft Software v.2.0.1 was now available for installation. The consignees were requested to complete and fax back the customer reply form indicating that they received the letter, and were informed that they would be contacted by a Baxter representative to schedule an installation of the software upgrade at no charge.

Device

Device Recall RenalSoft
  • Modèle / numéro de série
    Version 2.0 - HD Module, Serial Numbers 17023766 to 17026503
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA including Puerto Rico, and countries of Australia, Austria, Canada, Chile, Denmark, Finland, Greece, Ireland, Italy, Mexico, The Netherlands, New Zealand, Norway, Panama, Portugal, Spain, Sweden and the United Kingdom
  • Description du dispositif
    Baxter RenalSoft v.2.0 Patient Management Software Suite - HD Module; clinical data management software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085
  • Manufacturer
    Baxter Healthcare Renal Div

Manufacturer

Baxter Healthcare Renal Div
  • Adresse du fabricant
    Baxter Healthcare Renal Div, 1620 Waukegan Rd Bldg R, Mc Gaw Park IL 60085-6730
  • Source
    USFDA