Events

Recall of Device Recall Syndeo PCA Syringe 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
    32589
  • Event Risk Class
    Class 2
  • Event Number
    Z-1373-05
  • Event Initiated Date
    2005-07-06
  • Event Date Posted
    2005-08-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40398
  • 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
    infusion pump - Product Code MEA
  • Reason
    During an infusion in the 'basal + pca' or 'pca only' modes, the syndeo pump may generate false service code 919 or service code 920, which will cause the pump to stop the infusion. also, while attempting to turn on the device by pressing the on/off key, the pump may not power up properly.
  • Action
    Baxter sent Important Product Information letters dated 7/6/05 to all Syndeo Pump customers, to the attention of the Director of Nursing, via first class mail. The letter informed the accounts of the scenarios they may experience regarding Service Codes 919 and 920, and the pump not being able to power up properly. Mitigation for Service Codes 919 and 920 is to turn the pump off, then turn it on again, and reprogram the infusion. If the codes occur again, the accounts were instructed to take the pump out of service and contact Baxter Medication Delivery Services at 1-800-843-7867. Any questions were referred to the Center for One Baxter at 1-800-422-9837. Baxter sent Product Withdrawal letters dated 12/11/09 to all Syndeo Pump customers, to the attention of the Director of Materials Management, with copies to the Director of Biomedical Engineering and the Director of Nursing. The letters informed the accounts that Baxter has stopped further development of the Syndeo pump platform, will pursue next generation PCA syringe pump technology and execute a controlled product withdrawal of the Syndeo pump over the next 12 months. Baxter sales representatives will contact the customers in the next few weeks to discuss options, including a Syndeo pump "buy back" plan, and to present alternative Baxter products to meet the customer's needs. The letters included a list of Syndeo pump serial numbers specific for each account, and requested the accounts to forward the letter to other facilities that they may have provided with Syndeo pumps. The accounts were requested to complete and fax back to Baxter the enclosed customer reply form, acknowledging receipt and understanding of the letter.

Device

Device Recall Syndeo PCA Syringe Pump
  • Model / Serial
    product codes 2L3113 and 2L3113R, all serial numbers
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada
  • Product Description
    Baxter Healthcare Corporation, Medication Delivery Division, Syndeo PCA Syringe Pump, product codes 2L3113 and 2L3113R;
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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