Events

Recall of Device Recall Spectrum

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
    61355
  • Event Risk Class
    Class 1
  • Event Number
    Z-1490-2012
  • Event Initiated Date
    2011-07-06
  • Event Date Posted
    2012-06-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-10-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107879
  • 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
    Recall expansion; the infusion pumps have the potential to fail causing inaccurate flow conditions during use. these conditions range from back flow to free flow, which could result in over-infusion. sigma's evaluation of subsequent complaints involving failed bearings indicated that the loss or degradation of bearing lubricant to be a more significant contributor to bearing failure than initially believed. based upon the results of the analysis of these additional failures, sigma determined that any bearings prior to the latest, improved design may be at risk for failure. sigma decided to expand the recall of the spectrum infusion pumps to include units manufactured from 1/18/2005 through 11/01/2010.
  • Action
    Sigma sent an URGENT Medical Device Recall Notifications letter dated July 6, 2011 via UPS mail the consignees informing them of the expansion of the Spectrum Infusion Pumps recall. Some consignees were notified by telephone. The letter identified the affected product, problem, actions to be taken, clinical precautions and recommendations. Additional information regarding this voluntary recall is available on Sigma's web site www.sigmapumps.com/Recall. Customers were provided the following instructions: (1) Confirm that you have the affected serial number(s) ranging from 700000 to 794213 in inventory using the Customer Response Form. Refer to attached list of known affected devices in your possession. Revise this list as required. (2) Immediately remove affected pumps from neonatal use until B. Braun BC 1000 back check valves are employed. (3) Respond to this notification within five (5) working days of receipt by faxing the enclosed Customer Response Form to the number noted on the form, calling (866) 482-2893 between the hours of 8am and 8pm (EDT) or e-mailing a scanned version of form to sigma2407@stericycle.com. (4) Within three weeks of receipt of the Customer Response Form, (which verifies the device serial numbers in your facility), SIGMA will issue a customized recall report for each facility identifying the specific affected serial numbers, SIGMA internal contacts, and the plan for coordination of pump return and repair. For any adverse reactions experienced with the use of this product should be reported to SIGMA at (800)-356-3454 ext. 300 and to FDA MedWatch either by: Phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178; Mail at MedWatch, FDA 5600 Fishers Lane, Rockville, MD 20857, or MedWatch website by linking to: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm.

Device

Device Recall Spectrum
  • Model / Serial
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide including Puerto Rico and the countries of Canada and Okinawa
  • Product Description
    Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion Pump -- Class 2 medical device -- SIGMA LLC, Medina, NY 14103 || Product Usage: || The Spectrum Infusion Pump is intended to be used for the controlled administration of intravenous fluids. These fluids may include blood, blood products or mixtures of pharmaceutical drugs for required patient therapy. The Spectrum is used in conjunction with legally marked intravenous administration sets and medications provided by the user. || The Master Drug Library is a software package that will add additional features to the Spectrum Infusion Pump. The Master Drug Library will permit electronic communications with the Spectrum pump and other external peripheral devices. The intended use of the Spectrum pump includes common drug error prevention, through the stand alone settings features of the pump. This includes drug parameter limits and associated drug name identification. With the Master Drug Library, the intended use is to reduce user errors associated with drug selection, drug dose rates, drug dose concentrations, and patient identification associated with the prescribed drug.
  • 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