Events

Recall of Device Recall Baxter 6060E Epidural Pump

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Baxter Healthcare Corp..

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
    32254
  • Event Risk Class
    Class 2
  • Event Number
    Z-1089-05
  • Event Initiated Date
    2005-06-13
  • Event Date Posted
    2005-08-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-06-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40646
  • 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
    There is an overinfusion condition in the intermittent mode where the pump may continue to deliver at the higher dose rate instead of switching to the lower keep open rate once the first dose is completed.
  • Action
    Baxter sent the 6/13/05 Urgent Device Correction letter to all Baxter 6060 and 6060E Infusion Pump customers to inform them of a software anomaly which allows the pump to overinfuse in the Intermittent mode of the 6060 pump if the following specific sequence of events occur: * the infusion is running in intermittent mode; * the pump is delivering at the Keep Open (KO) rate; * the pump is then powered off and on; * the clinician initiates new programming of the pump by selecting NO at the 'Resume KO Dose 1?' prompt and selecting YES at the 'Yes to Program' prompt; * the clinician powers the pump off and on again; * and the clinician selects YES at the 'Resume KO Dose 1?' prompt. Until the software upgrade is available, Baxter recommended that the accounts notify healthcare providers of the potential for an overinfusion condition in Intermittent mode if the above sequence is performed during an infusion, and to utilize the Lockout mode after programming the pump. Any questions were directed to Baxter''s Medication Delivery Services at 1-800-843-7867. The letter also informed the accounts of two patient deaths due to medication delivery errors resulting from improper programming of the infusion parameters into the 6060 and 6060E pumps, and reports where the infusion parameters were modified by untrained individuals, which may result in overinfusion or underinfusion conditions. The letter stressed that programming of the pump must be performed only by trained clinicians, or healthcare providers trained and deemed competent by trained clinicians or under the direct supervision of trained clinicians; the Lockout mode feature of the pump should be used to prevent unauthorized changes to the pump programming; and the pump security codes, which disable the Lockout mode, must not be released to anyone other than trained healthcare professionals. A copy of the warning from the Operator''s Manual was included with the letter. Any questions were referred to the Center fo

Device

Device Recall Baxter 6060E Epidural Pump
  • Model / Serial
    All serial numbers
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and internationally to Belgium, Germany, Finland, France, the United Kingdom, Ireland, Sweden, Norway, Canada, Japan, New Zealand and Australia.
  • Product Description
    Baxter 6060E Epidural Infusion Pump, product code 2L9351 and 606000-40EL; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60013 USA, made in Singapore
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Manufacturer Address
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA