Pump, Infusion, Pca

Device Code: 2673

Product Code(s): MEA

Device Classification Information

Device Type ID2673
Device NamePump, Infusion, Pca
Regulation DescriptionInfusion Pump.
Regulation Medical SpecialtyGeneral Hospital
Review PanelGeneral Hospital
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type510(k)
CFR Regulation Number880.5725 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeMEA
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID2673
DevicePump, Infusion, Pca
Product CodeMEA
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionInfusion Pump.
CFR Regulation Number880.5725 [🔎]
Premarket Reviews
ManufacturerDecision
HOSPIRA, INC
 
SUBSTANTIALLY EQUIVALENT
 1
HOSPIRA, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
SUMMIT MEDICAL PRODUCTS, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
Device Problems
Pump
 131
Device Displays Incorrect Message
74
Alarm, Audible
 72
Excess Flow Or Over-Infusion
 71
Device Inoperable
 71
Occlusion Within Device
 69
Failure To Sense
65
Infusion Or Flow Problem
 56
Failure To Deliver
 52
Bolus Mechanism
 46
Fluid Leak
 43
Insufficient Flow Or Under Infusion
 41
No Audible Alarm
 41
Loss Of Power
 37
Syringe
 32
Inaccurate Delivery
29
Device Alarm System
 27
Break
 17
Alarm
 11
Adverse Event Without Identified Device Or Use Problem
 11
Electrical /Electronic Property Problem
 10
Battery
 9
Cassette
 9
Thermal Decomposition Of Device
 8
Sensor
 7
Adapter (Adaptor)
 7
False Alarm
 6
Battery Problem
 6
Inaccurate Flow Rate
 5
Device Operational Issue
 5
Smoking
 5
Use Of Device Problem
 5
Charred
 5
Prong
 5
Output Problem
 4
Component Missing
4
Human-Device Interface Problem
 3
Bent
 3
Overheating Of Device
 3
Filling Problem
 3
Temperature Problem
 2
Delivery System Failure
 2
Improper Flow Or Infusion
 2
Naturally Worn
 2
Display
 2
Defective Alarm
 2
Volume Accuracy Problem
 2
Alarm, Power
 2
Power Cord
 2
Pressure Problem
 2
Tube
 2
Failure To Power Up
 2
Cap
 2
Sparking
 2
Programming Issue
 2
Nuts
 2
Improper Or Incorrect Procedure Or Method
 2
Power Problem
 2
Activation Problem
2
Inaccurate Dispensing
 2
Obstruction Of Flow
 2
No Display / Image
 2
Seal
 2
Lenses
 2
Increase In Pressure
 2
Device Difficult To Program Or Calibrate
 1
Self-Activation Or Keying
1
Invalid Sensing
 1
Premature Discharge Of Battery
1
Circuit Failure
 1
Wire
 1
Capacitor
 1
Jack
 1
Connection Problem
 1
Electrical Power Problem
 1
Regulator
 1
Pressure Sensor
 1
Melted
 1
Failure To Pump
 1
Difficult To Open Or Close
 1
Unknown (for Use When The Device Problem Is Not Known)
 1
No Flow
 1
Charging Problem
1
Material Integrity Problem
 1
Inappropriate Shock
 1
PC (Printed Circuit) Board
 1
Keypad
 1
Incorrect Software Programming Calculations
 1
Application Program Problem
 1
Material Protrusion / Extrusion
 1
Device Handling Problem
 1
Intermittent Loss Of Power
 1
Device Emits Odor
 1
Unsealed Device Packaging
 1
Keyboard
 1
Motor
 1
Image Display Error / Artifact
 1
Failure To Infuse
 1
Device Contamination With Chemical Or Other Material
 1
Device Damaged Prior To Use
1
Total Device Problems 1193
Recalls
Manufacturer Recall Class Date Posted
1
Baxter Healthcare Corp.
 II Apr-27-2015
2
CareFusion 303, Inc.
 II Jan-08-2018
3
Hospira Inc.
 II Sep-22-2016
4
Hospira Inc.
 II Jul-08-2016
5
Hospira Inc.
 II Apr-23-2015
6
Smiths Medical ASD Inc.
 II Feb-01-2018
7
Smiths Medical ASD, Inc.
 II Mar-10-2017
8
Smiths Medical ASD, Inc.
 II Jun-18-2015
9
Smiths Medical ASD, Inc.
 II Nov-01-2014
TPLC Last Update: 2019-04-02 20:17:12
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