Cadd-Ms 3 Ambulatory Infusion Pump

• • Terminated Z-1621-2008 FDA Unclassified (pre-2012) ·initiated 7 Mar 2008

  Smiths Medical discovered an issue with a motor component in specific serial numbers of the CADD-MS 3 Ambulatory Infusion Pump. This issue affects motor operation and may cause an over-delivery of medication which could result in injury to the user.

• • Terminated Z-1641-2008 FDA Unclassified (pre-2012) ·initiated 22 Feb 2008

  Smiths Medical has received reports that the device powers down without an alarm. Investigation concluded that if the battery cap is not fully tightened, the pump may power down and a brief "chirp" will sound. This may occur if the user has not sufficiently tightened the battery cap or if the battery cap is damaged. If a patient is asleep or does not regularly check their Pump, there is a potentia

510(k) Number

K051568 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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See all devices from Smiths Medical MD, Inc. →