Events

Rappel de Device Recall Plum 360 Infusion Pump

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., A Pfizer Company.

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
    76253
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1682-2017
  • Date de mise en oeuvre de l'événement
    2016-12-30
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152590
  • 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
    Depleted battery alarm shows instead of replace battery. on battery power, ongoing therapy stops, alarms show and sound, pump shuts down after 3 minutes. on ac power, the pump reboots (takes about 25 seconds). therapy can resume. ac power interruption of 3-7 seconds prompts an incorrect e323 alarm, ongoing therapy stop, and pump reboot. longer power loss results in battery power operation.
  • Action
    On 12/30/2016, firm sent notification of the recall to Hospira direct consignees of record via traceable mailing. Delivery will be confirmed via traceable mailing. Consignees who further distributed the product were asked to notify their customers. Effectiveness of the communication will be confirmed by phone call with direct consignees who do not respond. The final disposition of the recalled product will be field correction (firm will contact consignees to upgrade the software in their Plum 360 infusion pumps).

Device

Device Recall Plum 360 Infusion Pump
  • Modèle / numéro de série
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, Australia, New Zealand, Canada, Mexico, Chile, Philippines, Hong Kong, Greece, Ireland, Jordan, Kuwait, Oman, Poland, Saudi Arabia, Turkey, United Arab Emirates, Italy, France, United Kingdom, Spain
  • Description du dispositif
    Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions
  • Manufacturer
    Hospira Inc., A Pfizer Company

Manufacturer

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