Events

Recall of Device Recall Alaris Pump Module model 8100

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by CareFusion 303, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    55121
  • Event Risk Class
    Class 1
  • Event Number
    Z-2185-2012
  • Event Initiated Date
    2012-06-29
  • Event Date Posted
    2012-08-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89956
  • Notes / Alerts
    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.
  • Extra notes in the data
    Pump, infusion - Product Code FRN
  • Reason
    The recall was initiated because carefusion identified a potential risk associated with the alaris pump module model 8100. carefusion has received reports of customers experiencing motor stalls during infusion with alaris pump module (model 8100) manufactured between august 2010 and july 2011.
  • Action
    CareFusion sent an Urgent Medical Device Recall Notification letter dated July 20, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Required action for users instructed high risk patients undergoing infusions at high rates, consider having additional devices as back up. Clinicians should weigh the risk/benefit to the patients before continuing to use the device. Customers with recall related questions were instructed to contact Carefusion support center at (888) 562-6018. Customers with adverse event report questions were instructed to contact customer advocacy at (800) 854-7128, option 1, option 1, option 3 or email at customerfeedback@carefusion.com. Customers with technical questions regarding the Alaris system were instructed to contact Technical support at (888) 812-3229. For questions regarding this recall call 858-617-4000.

Device

Device Recall Alaris Pump Module model 8100
  • Model / Serial
    All serial numbers associated with the Alaris Pump Module Model 8100: 8100 DEMO PUMP MODULE; 8100 Global Pump Module; 8100 IOC Pump Module V8.5.29.0; 8100 LVP Training Unit; 8100 Pump Module V8.5.29.0; 8100 Pump Module V8.5.29.0 (V9); Medley Patient Care System LVP; Model 8100 Trade-In Material; RCND 8100 Pump Module V8.5.29.0
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of: South Africa and Canada. Additional Countries: Netherlands.
  • Product Description
    Alaris Pump Module model 8100. || Subsequent product code: FPA || The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), intra-arterial (IA),subcutaneous, epidural, enteral, or irrigation of fluid spaces. The Pump module is indicated for use on adults, pediatrics, and neonates.
  • Manufacturer
    CareFusion 303, Inc.

Manufacturer

CareFusion 303, Inc.
  • Manufacturer Address
    CareFusion 303, Inc., 10020 Pacific Mesa Blvd, San Diego CA 92121-4386
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA