Purpose of this Addendum
This addendum provides patients, technicians, and caregivers additional information important to
the safe and effective use of the Curlin PainSmart™ IOD ambulatory infusion system.
The Curlin PainSmart™ IOD infusion system has been designed to meet/exceed all international
standards for ruggedness and performance associated with an ambulatory medical product in
normal use. In recent months, Curlin has seen an increase in the number of pumps involved in
over-infusion or free-flow incidents where the pump has been dropped with the door open
resulting in deformation of the door and a loss of delivery accuracy.
To help reduce the number of these incidents and to improve the prominence of cautionary
statements already in the operator’s manual, Curlin is making the following modifications to the
operator’s manual (P/N 360-9043).
In addition, the Volumetric Delivery Test in the User Manual has been improved to provide better
test resolution in determining accuracy and the possibility of a free-flow condition. Therefore, this
addendum also modifies the method for executing the Volumetric Delivery Test.
Page 5
Caution Bullet Number 2 on page 5 of the User Manual has been elevated to a Warning. The text
has not been modified. It reads as follows.
•Visually inspect the pump, pumping chamber and administration set before use. Do not use
any pump or administration set that appears to be damaged or tampered with or if there is any
indication of improper function.
Caution Bullet Number 13 on page 5 of the User Manual has been elevated to a Warning. The text has
been modified as follows:
•Do not subject the pump to dropping or hitting against a hard surface. If at any time the pump
is dropped or hit, the pump must be checked for volumetric accuracy prior to reuse. The pump
can only be brought back into service if the volumetric accuracy test passes per the user
manual. If the pump fails volumetric accuracy it must be returned to Curlin Medical for
evaluation.
Page 116
Replace the Purpose Statement with the following:
Procedure for Checking Pumps Between Patients
Purpose
This procedure is provided for use by caregivers to ensure pumps meet all critical performance
specifications prior to use of the product on new patients. This procedure is for use by
technicians to inspect, test, and prepare a pump for use by a new patient. The test checks for
volumetric accuracy and all pump safety systems. Also, various parameters are initialized.
360-9043-ADD-02 Rev. C
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