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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pump, infusion, pca
Regulation Description Infusion pump.
Product CodeMEA
Regulation Number 880.5725
Device Class 2


Premarket Reviews
ManufacturerDecision
HOSPIRA, INC
  SUBSTANTIALLY EQUIVALENT 1
HOSPIRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUMMIT MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Pump 131
Excess Flow or Over-Infusion 121
Insufficient Flow or Under Infusion 80
Infusion or Flow Problem 78
Device Displays Incorrect Message 74
Alarm, Audible 72
Device Inoperable 71
Occlusion Within Device 69
Failure to Sense 65
Failure to Deliver 52
Bolus Mechanism 46
Inaccurate Delivery 45
Fluid Leak 43
No Audible Alarm 41
Loss of Power 38
Syringe 32
Volume Accuracy Problem 30
Device Alarm System 29
Break 17
Alarm 12
Adverse Event Without Identified Device or Use Problem 11
Cassette 10
Electrical /Electronic Property Problem 10
Battery 9
Sensor 8
Thermal Decomposition of Device 8
Inaccurate Flow rate 7
Adapter (Adaptor) 7
False Alarm 6
Battery Problem 6
Device Operational Issue 5
Prong 5
Charred 5
Smoking 5
Use of Device Problem 5
Output Problem 4
Component Missing 4
Human-Device Interface Problem 3
Improper Flow or Infusion 3
Pressure Problem 3
Increase in Pressure 3
Overheating of Device 3
Bent 3
Filling Problem 3
Alarm, Visual 3
Alarm, Power 2
Cap 2
Display 2
Seal 2
Power Cord 2
Screen 2
Defective Alarm 2
Tube 2
Lenses 2
Nuts 2
No Display / Image 2
Failure to Power Up 2
Failure to Pump 2
Programming Issue 2
Temperature Problem 2
Activation Problem 2
Inaccurate Dispensing 2
Device Sensing Problem 2
Power Problem 2
Naturally Worn 2
Delivery System Failure 2
Improper or Incorrect Procedure or Method 2
Sparking 2
Failure to Infuse 2
Obstruction of Flow 2
Failure to Calibrate 1
Cut In Material 1
Unknown (for use when the device problem is not known) 1
Device Damaged Prior to Use 1
Invalid Sensing 1
Application Program Problem 1
Charging Problem 1
Connection Problem 1
No Flow 1
Insufficient Information 1
Device Handling Problem 1
Patient Device Interaction Problem 1
Intermittent loss of power 1
Difficult to Open or Close 1
Electrical Power Problem 1
Device Contamination with Chemical or Other Material 1
Material Integrity Problem 1
Material Protrusion / Extrusion 1
Scratched Material 1
Pumping Stopped 1
Self-Activation or Keying 1
Inappropriate Shock 1
Unstable 1
Incorrect Software Programming Calculations 1
Device Difficult to Program or Calibrate 1
Unsealed Device Packaging 1
Device Emits Odor 1
Display or Visual Feedback Problem 1
Premature Discharge of Battery 1
Circuit Failure 1
Total Device Problems 1365

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

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