Events

Rappel de Device Recall Alaris System InterUnit Interface (IUI) Connectors

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 Cardinal Health 303 dba Cardinal Health.

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
    52119
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1794-2009
  • Date de mise en oeuvre de l'événement
    2009-06-12
  • Date de publication de l'événement
    2009-08-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82452
  • 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
    There is a potential risk of iui connector failure in the alaris system when these connectors become corroded or contaminated, which may result in an interruption of infusion with an audible and visual alarm. iui connectors can become corroded or contaminated when exposed to fluid spills or improper cleaning. this notification is to reinforce the importance of inspection of iui connectors prior.
  • Action
    The recall was initiated on June 12, 2009 with the firm forwarding via UPS an Urgent: Medical Device Recall Notification with attached Customer Response Card to the Chief Administrative Officer, Director of Pharmacy, Director of Biomedical Engineering, Director of Nursing & Director of Risk Management of all of the affected consignees. Customers were also asked to please promptly complete and return the enclosed Customer Response Card to expedite the correction process. The Recall Notification informed the consignees of: (A) PROBLEM #1: Occlusion Warning Message for Alaris Pump Module; (B) PROBLEM #2 Syringe volume Warning Message for Alaris PCA module; (C) PROBLEM #3 Electrostatic Discharge (ESD) protection circuitry; (D) PROBLEM #4 Fluid Ingress and (E) PROBLEM #5 Alaris System Inter-Unit Interface (IUI) Connectors Labeling. The recall notice included "Required Action for Users & Follow-up actions by Cardinal Health for all five problems. Customers were also asked to report any adverse reactions experienced with the use of this product, and/or quality problems to the FDA's MedWatch Program. In addition, customer were provided the following contact information for the recall: (1) Cardinal Health Recall Center for general questions: By phone at 1-888-562-6018 7am to 5pm (Pacific) ; (2) Customer Advocacy for adverse reports: By phone at 1-800-854-7120, Option 1, Option 1, Option 3 or by email at customerfeedback@cardinalhealth.com 24 hours a day, Sunday-Saturday; (3) Technical Support for Technical Questions regarding the Alaris System: By phone at 1-888-562-6018, 6am-5pm (Pacific). The firm followed-up with the release of a nationwide press statement regarding this issue on July 29, 2009. The press release indicated serial numbers of affected devices, as well as CareFusions short term instructions to customers, and the firms strategy to fix the affected devices can be found at: www.cardinalhealth.com/alaris/medical-device-recall/ (This informatio

Device

Device Recall Alaris System InterUnit Interface (IUI) Connectors
  • Modèle / numéro de série
    The Modules include the following: Alaris PC Unit, Model 8000 and 8015; Alaris Pump Module, Model 8100;  Alaris Patient-Controlled Analgesia (PCA), Model 8120; Alaris Syringe Module, Model 8110;  Alaris SpO2 Module, Model 8210 and 8220 and  Alaris EtCO2 Module, Model 8300.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- US (including Puerto Rico and Guam), Germany, England, Canada, Netherlands, Malaysia, Singapore, Australia, and New Zealand.
  • Description du dispositif
    Alaris System Inter-Unit Interface (IUI) Connectors. The Modules include the following: Alaris PC Unit, Model Numbers 8000 and 8015; || Alaris Pump Module, Model 8100; || Alaris Patient-Controlled Analgesia (PCA), Model 8120; || Alaris Syringe Module, Model 8110; || Alaris SpO2 Module, Model 8210 and 8220 and || Alaris EtCO2 Module, Model 8300.
  • Manufacturer
    Cardinal Health 303 dba Cardinal Health

Manufacturer

Cardinal Health 303 dba Cardinal Health
  • Adresse du fabricant
    Cardinal Health 303 dba Cardinal Health, 10020 Pacific Mesa Blvd, San Diego CA 92121-4386
  • Société-mère du fabricant (2017)
    Cardinal Health
  • Source
    USFDA