Events

Rappel de Device Recall ONQ pump with ONDEMAND bolus button

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 I-Flow Corporation.

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
    62769
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-2253-2012
  • Date de mise en oeuvre de l'événement
    2012-05-08
  • Date de publication de l'événement
    2012-08-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-04-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111679
  • 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, elastomeric - Product Code MEB
  • Cause
    It was determined that in a small quantity of on-q pumps with ondemand, the bolus button may not lock in the down position when depressed and/or the orange bolus refill indicator may stay in the lowermost position. as a result, the patient may receive continuous infusion at a rate greater than expected.
  • Action
    An Important Voluntary Recall Notice letter dated 5/8/12 was sent to all their customers who purchased the ON-Q pump with ONDEMAND bolus button. The letter provided customers with the problem indicated and the actions to be taken. Customers were instructed to complete and sign the attached Recall Response Form and fax to (920)969-4565 or scan and email to IflowProductInquiry@kcc.com. Once I-Flow receives the completed FAX BACK form, an I-Flow Customer Service Representative will immediately contact the customers to provide instructions on product return and credit. Customers with questions regarding the recall letter, were instructed to contact I-Flow Customer Service between 8am to 5pm (PST) at (800) 443-3569. Or customers can contact I-Flow 24 hour Technical Support line at (800) 444-2728.

Device

Device Recall ONQ pump with ONDEMAND bolus button
  • Modèle / numéro de série
    Products having a 10-digit Lot # that is greater than 0200521454 (i.e. 0200521455 and greater) are not impacted by this recall.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, Canada, Australia, the EU (Germany), United Arab Emirates, and Cyprus.
  • Description du dispositif
    ON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND; ON-Q C-bloc with Select a Flow and ONDEMAND Model/Reference #: 7000180, 7000181, 7000182, 7000367, 7000397, CB003, CB005, CB006, P400X1-7+5/60, P400X2-14+5/30, P400X5+5/60, and PMB01. || Part Numbers: 101347100, 101347300, 101347400, 101360200, 101368400, 101368600, 101368700, 102987000, 102987200, 102987300, 103161800, 103534300, 5001438, 5001470, 5001651, 5001780, 5001808, 5001809, 5001812, 7000180, 7000181, 7000182, & 7000367. || Indicated for continuous and or intermittent delivery of medication to or around surgical wound sites and or close proximity to nerves.
  • Manufacturer
    I-Flow Corporation

Manufacturer

I-Flow Corporation
  • Adresse du fabricant
    I-Flow Corporation, 20202 Windrow Dr, Lake Forest CA 92630-8152
  • Source
    USFDA