Events

Rappel de Plum A Single Channel Infusion Pumps with MedNet Software

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 Hospira 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
    63518
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0483-2013
  • Date de mise en oeuvre de l'événement
    2012-10-26
  • Date de publication de l'événement
    2012-12-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-11-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114655
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notes supplémentaires dans les données
    Pump, infusion - Product Code FRN
  • Cause
    The volume control knob on some plum a+ single channel infusers (located on the back of the infuser) may not function as described in the system operating manual - the direction for loud and quiet may be reversed. the manual indicates a clockwise rotation of the knob decreases the volume; however, on some of the devices the alarm volume increases when the knob is turned clockwise.
  • Action
    The firm, Hospira Inc. sent "URGENT DEVICE FIELD CORRECTION" letters dated October 26, 2012 to all affected customers. The letters identified the products, problem and action(s) to be taken. The customers were instructed to read the information provided carefully, complete the attached Reply Form and return it to the firm via fax at 1-877-650-8667. The letter states that the System Operating Manual will be updated to clarify the instructions for setting the volume, and that the updated manuals will be sent as soon as they are available. Customers were instructed to notify their consignees if they have further distributed the affected product. The customers were requested to contact Hospira Advanced Knowledge Center at 1-800-241-4002, option 4, for additional information and technical assistance.

Device

Plum A Single Channel Infusion Pumps with MedNet Software
  • Modèle / numéro de série
    pump list numbers 20679 and 20792, and module list number 20677; all serial numbers
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including Puerto Rico, and the countries of Australia, Bahrain, Belgium, Brazil, Canada, Chile, Colombia, Denmark, France, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Libya, Malaysia, Mexico, Netherlands, New Zealand, Oman, Pakistan, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Lavenia, South Africa, Spain, Switzerland, Taiwan, Turkey, United Kingdom, United Arab Emirates and Vietnam.
  • Description du dispositif
    Plum A+ Single Channel Infusion Pumps with Hospira Mednet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local area networking, allowing the MedNet software to download drug libraries to the infuser and enable the auto-programming feature; Hospira, Inc., Lake Forest, IL 60045; pump list #20679 and 20792, module list number 20677. || The Plum A+ Infusion System with Hospira MedNet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local area networking, allowing the MedNet software to download drug libraries to the infuser and enable the auto-programming feature.
  • Manufacturer
    Hospira Inc.

Manufacturer

Hospira Inc.
  • Adresse du fabricant
    Hospira Inc., 275 N Field Dr, Lake Forest IL 60045-2579
  • Société-mère du fabricant (2017)
    Pfizer
  • Source
    USFDA