Sigma Spectrum Infusion Pump Model 35700:
Class 1 Recall: Risk of
Over-Infusion
Audience: Risk Manager, Nursing
Issue: FDA notified healthcare professionals of the class 1
recall of
the SIGMA Spectrum Infusion Pump Model 35700. 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. These conditions could result in
serious
injury or death.
Background: The recalled 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.
Recommendations: 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.
Read the MedWatch safety alert, including a link to the FDA
Recall
Notice, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm233747.htm
You are encouraged to report all serious adverse events and
product
quality problems to FDA MedWatch at
www.fda.gov/medwatch/report.htm
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