Events

Rappel de Device Recall InfusO.R.

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
    57666
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1378-2011
  • Date de mise en oeuvre de l'événement
    2011-01-10
  • Date de publication de l'événement
    2011-02-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96943
  • 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
    Infusion Pump - Product Code FRN
  • Cause
    Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (.53 inches), an electrical circuit will not be completed and the infusor will not operate. the reason being that the infusor (2l3100) battery spring has a flat contact that measures .53 inches ¿.01 inches on the inner diameter of the spring coil. the iec 60086-2 and ansi 08 standards specify a minimum.
  • Action
    Safety Alert letters dated January 11, 2011 were mailed via first class mail to the InfusOR direct accounts, to the attention of the Director of Biomedical Engineering, the Director of Anesthesia and the Director of Materials Management, on the same date, informing them that over-the-counter Energizer C size alkaline batteries should not be used with the InfusO.R. Pumps (Product codes 2L3100, 2L3100R, 2L3100R, 2L3100U, 2L3100N, 6461500 and 6461500R). That particular battery incorporates a feature that may inhibit electrical contact and affect the ability of the pump to power-up. The accounts were requested to check their inventory of InfusO.R. Pumps for the presence of over-the-counter Energizer C size alkaline batteries. The accounts were also requested to complete the attached customer reply form confirming their receipt of the letter and fax it to Baxter at the number provided on the form. Any questions regarding the communication were directed to The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST. *** Baxter expanded the scope of their action to include the Mini-Infuser System and sent Urgent Device Correction letters dated 3/4/11 via First Class mail to all InfusOR and Mini-Infuser customers who had purchased either of the affected product lines. The letters informed the accounts that the Mini-Infusers use the same size battery and incorporate the same battery contact interface as the InfusOR pump, and that the same feature that inhibits electrical contact in over-the counter Energizer C size batteries may also be incorporated by other battery manufacturers. The accounts were requested to verify that the InfusOR and Mini-Infuser will power-on before use; if the device does not power on, replace the batteries with a different brand of size C batteries and verify that the device will power-on before use; and to place a copy of the letter with each operator's manual for the InfusOR and Mini-Infuser System for future refer

Device

Device Recall InfusO.R.
  • Modèle / numéro de série
    All serial numbers.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    InfusO.R. Infusion Pump, an Rx syringe infusion pump; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.; product codes 2L3100, 2L3100R, 2L3100U, 6461500 and 6461500R. These product codes includes refurbished units and InfusO.R. pumps previously sold under the Bard label. || Intended for the controlled rate delivery of small volume parental fluids as prescribed by a physician.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Adresse du fabricant
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA