Events

Recall of Sigma Spectrum Infusion Pump with master Drug Library Version 6.

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

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
    79815
  • Event Risk Class
    Class 2
  • Event Number
    Z-1665-2018
  • Event Initiated Date
    2018-04-03
  • Event Date Posted
    2018-05-04
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163556
  • 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
    Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omitted tests include air-in-line detection at 400ml/hr and 800ml/hr and verification of upstream occlusion detection at 800ml/hr. improper detection of air-in-line or upstream occlusion may result in serious adverse health consequences.
  • Action
    On 4/3/18, Baxter HealthCare Corporation mailed URGENT MEDICAL DEVICE CORRECTION notices and Reply Forms to customers via first class mail. Actions to be Taken by Customers: 1. Locate and discontinue use of all affected pumps at your facility. 2. Return the device to Baxter for testing. To arrange for return of affected devices, contact Baxter at 800-356-3454 between the hours of 7:00 am and 7:00 pm Eastern Time, Monday through Friday. Please have your Baxter 8-digit ship-to account number, product code, serial number, and quantity of devices to be returned ready when calling. 3. If you purchased this product directly from Baxter, complete the enclosed Baxter Customer Reply Form and return it to Baxter by faxing it to 224-270-5457 or via email to fca@baxter.com even if you do not have inventory. 4. If you purchased this product from a distributor, please note that the Baxter customer reply form is not applicable. If a reply form is provided by your distributor or wholesaler, please return it to the supplier according to their instructions. 5. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them. 6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers.

Device

Sigma Spectrum Infusion Pump with master Drug Library Version 6.
  • Model / Serial
    Serial numbers   745365 750241 750330 752814 754975 757930 762405 763117 764490 768855 772652 773031 773134 773520 774413 778845 779430 779822 781545 782706 782985 783185 787001 793146 833195 865842 883498 883854 889556 889775 890230 891398 891421 891647 891689 901881 917897 917963 919594 919736 919837 921078 921819 924734 928406 937123 940345 940860 940949 941786 944619 966019 990542 996435 996823 997156 998126 1011229 1011544 1014955 1027799
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide & Puerto Rico
  • Product Description
    Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR || Product Usage: || The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The Spectrum and Spectrum with MAster Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming.
  • Manufacturer
    Baxter Healthcare Corporation

Manufacturer

Baxter Healthcare Corporation
  • Manufacturer Address
    Baxter Healthcare Corporation, 711 Park Ave, Medina NY 14103-1036
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA