Class I Recall for Spectrum Infusion Pump

The U.S. Food and Drug Administration (FDA) just notified healthcare professionals of the Class 1 recall of the <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">SIGMA Spectrum Infusion Pump Model 35700. Class I recalls are the FDA’s the most serious type of recall and involve situations in which there is a reasonable probability that use of the recalled products will cause serious adverse health consequences or death.



These units may fail suddenly, causing inaccurate flow conditions during use, ranging from back flow to over-infusion, including free flow. The pump does not issue an alarm when this occurs and these conditions could result in serious injury or death.

The recalled SIGMA Spectrum Infusion Pump is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood, and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration. The recall was initiated September 15, 2010 and includes serial numbers from 706497 to 724065.

Sigma has instructed healthcare facilities to verify whether the serial numbers for their infusion pumps fall within the range of pumps being recalled and is requiring the return of the recalled devices. Sigma has instructed users to not use the infusion pumps on patient populations, including neonatal patients, where inaccurate flow, ranging from back flow to over-infusion, including free flow, could result in serious adverse health consequences or death.

The affected, recalled SIGMA Spectrum Infusion Pumps were manufactured from October 2006 to March 2008 by Sigma International General Medical Apparatus, LLC
711 Park Avenue
Medina, New York 14103-1036

Sigma International can be reached, toll-free, at 1-866-482-2893, Monday through Friday, from 8:00 a.m. through 5:00 p.m., Eastern Time.

On or about September 15, 2010, Sigma International sent its customers a recall notice (see under Useful Links below) by certified mail. The letter informed the company’s customers about the recall since these units may fail suddenly causing inaccurate flow conditions during use.

The letter instructed customers to check their inventory to verify if their serial numbers fall within the range of pumps being recalled. Due to the possible failure of these units, SIMGA is servicing or replacing all affected Spectrum infusion pumps and is requiring the return of the recalled devices to its facility.

SIGMA provided the following instructions for users:

DO NOT USE the affected Spectrum infusion pumps on patient populations where inaccurate flow, ranging from back flow to over-infusion, including free flow, could result in serious adverse health consequences or death.

DO NOT USE on neonatal patients. If the facility does not have acceptable alternative methods for delivering therapy, the user should weigh the risks and benefits for the continued use of the affected pumps.

If these pumps must be used, SIGMA recommends the following actions, which may reduce the risk: For pediatric and adult patients, an add-on buretrol may limit the amount of an over-infusion if the failure occurs. Always follow the buretrol manufacturer’s instructions. Consider using air-eliminating filters. Under free flow conditions, pumps cannot stop fluid flow. If air is in the line with fluid, the air will also infuse. Frequently observe that the drip rate (mL/hr) compares to the programmed pump flow. Also make an observation of the container volume to ensure it is correct. If a discrepancy is observed, immediately remove the pump from service and treat the patient as appropriate.

SIGMA additionally provided instructions to customers for the return of affected pumps.

Help filing claims and other legal assistance for the victims of the defective, recalled SIGMA Spectrum Infusion Pump Model 35700is available <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">here.

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