Class I Baxter Sigma Spectrum Infusion Pumps

Company: Baxter Healthcare Corporation
Date of Enforcement Report:2/7/2014
Class I:

PRODUCT

Sigma Spectrum Infusion Pumps with Master Drug Library Model No. 35700BAX and 35700ABB

Affected products were manufactured from July 1, 2005 through January 15, 2014 and distributed from February 20, 2013 through January 15, 2014.

Use: Sigma Spectrum Infusion Pumps with Master Drug Library are intended to deliver controlled amounts of intravenous fluids including medicines, blood, blood products and other mixtures required by patients. The routes of administration include a vein or an artery, under the skin, into the spine, and other acceptable routes. The Sigma Spectrum Infusion Pumps with Master Drug Library are used in, but not limited to, hospitals, outpatient care, and home care.

REASON
Baxter has received over 3500 reports of System Error 322 ?Link Switch Error (low)? incidents in which the device has malfunctioned, including nine severe adverse events and no deaths. The System Error 322 occurs when the pump improperly detects that the door is open when it is physically closed. A System Error 322 may lead to an interruption or delay in therapy.

If the System 322 occurs, the Sigma Spectrum infusion pump stops the infusion, an alarm sounds, and a light flashes (a visual ?322? alarm). This requires a clinician to reset the alarm, reprogram the pump, and confirm the infusion is running properly.

The use of affected product may cause serious adverse health consequences, including death.

RECALLING FIRM/MANUFACTURER
Baxter Healthcare Corporation, Deerfield, Illinois. on 2/14/2014.

___________________________________

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

Email office@softwarecpr.com
for more info!

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.