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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

MDR Year MDR Reports MDR Events
2016 56 56
2017 43 43
2018 257 257
2019 130 130
2020 2312 2312

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 1458 1458
Break 1216 1216
Device Markings/Labelling Problem 970 970
Corroded 527 527
Deformation Due to Compressive Stress 434 434
Appropriate Term/Code Not Available 417 417
Naturally Worn 307 307
Misassembled 205 205
Excess Flow or Over-Infusion 156 156
Device Sensing Problem 144 144
Pump 137 137
No Apparent Adverse Event 115 115
Infusion or Flow Problem 114 114
Degraded 109 109
Display or Visual Feedback Problem 107 107
Computer Software Problem 98 98
Physical Resistance/Sticking 93 93
Failure to Analyze Signal 88 88
Insufficient Flow or Under Infusion 85 85
Circuit Failure 81 81
Failure to Calibrate 81 81
Contamination 73 73
Device Displays Incorrect Message 70 70
Inaccurate Delivery 51 51
Device Alarm System 47 47
Volume Accuracy Problem 43 43
Application Program Freezes, Becomes Nonfunctional 40 40
Failure to Read Input Signal 30 30
Insufficient Information 29 29
Fluid Leak 17 17
Calibration Problem 17 17
Electrical /Electronic Property Problem 15 15
Alarm 14 14
Battery Problem 13 13
Communication or Transmission Problem 13 13
Improper Flow or Infusion 12 12
Cassette 11 11
Adverse Event Without Identified Device or Use Problem 10 10
False Alarm 10 10
Inaccurate Flow Rate 10 10
Device Operates Differently Than Expected 9 9
Failure to Power Up 9 9
Use of Device Problem 8 8
Sensor 8 8
Battery 8 8
Improper or Incorrect Procedure or Method 8 8
Failure to Infuse 7 7
Occlusion Within Device 7 7
Display Difficult to Read 7 7
Pumping Stopped 7 7
Output Problem 7 7
Mechanics Altered 6 6
Increase in Pressure 5 5
Pressure Problem 5 5
Connection Problem 5 5
Noise, Audible 5 5
Loss of Power 5 5
Component Missing 5 5
Application Program Problem 5 5
Charred 5 5
Failure to Cycle 4 4
Application Program Version or Upgrade Problem 4 4
No Display/Image 4 4
Application Program Problem: Medication Error 4 4
No Flow 4 4
Device Contamination with Chemical or Other Material 4 4
Leak/Splash 4 4
Power Cord 4 4
Defective Alarm 4 4
Missing Information 4 4
Complete Loss of Power 3 3
Alarm, Visual 3 3
Loose or Intermittent Connection 3 3
Material Discolored 3 3
Device Inoperable 3 3
Programming Issue 3 3
Failure to Deliver 3 3
Device Slipped 3 3
Smoking 3 3
Computer System Security Problem 3 3
Failure to Align 3 3
Filling Problem 3 3
Adapter (Adaptor) 2 2
Seal 2 2
Tube 2 2
Failure to Charge 2 2
Lenses 2 2
No Audible Alarm 2 2
Delivery System Failure 2 2
Inaccurate Dispensing 2 2
Difficult to Open or Close 2 2
Inaccurate Synchronization 2 2
Incorrect, Inadequate or Imprecise Resultor Readings 2 2
Failure to Sense 2 2
Obstruction of Flow 2 2
Protective Measures Problem 2 2
Temperature Problem 2 2
Activation Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Integrity Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 2282 2282
No Known Impact Or Consequence To Patient 196 196
No Consequences Or Impact To Patient 185 186
No Information 143 143
Not Applicable 13 13
Overdose 13 13
Pain 10 10
Death 8 8
No Clinical Signs, Symptoms or Conditions 7 7
Underdose 4 4
Dizziness 4 4
Cardiac Arrest 3 3
High Blood Pressure/ Hypertension 3 3
Low Blood Pressure/ Hypotension 3 3
Low Oxygen Saturation 2 2
Oversedation 2 2
Insufficient Information 2 2
Respiratory Distress 2 2
Anxiety 2 2
Inadequate Pain Relief 2 2
No Code Available 2 2
Chest Tightness/Pressure 1 1
Patient Problem/Medical Problem 1 1
Complaint, Ill-Defined 1 1
Brain Injury 1 1
Convulsion, Clonic 1 1
Shock 1 1
Tachycardia 1 1
Blurred Vision 1 1
Bradycardia 1 1
Hypoxia 1 1
Nausea 1 1
Decreased Respiratory Rate 1 1
Decreased Sensitivity 1 1
Coma 1 1
Diaphoresis 1 1
Pallor 1 1
Ischemia 1 1
Neurological Deficit/Dysfunction 1 1
Aneurysm 1 1
Cardiopulmonary Arrest 1 1
Dyspnea 1 1
Fatigue 1 1
Gastritis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CareFusion 303, Inc. II Jan-08-2018
2 Hospira Inc. II Sep-22-2016
3 Hospira Inc. II Jul-08-2016
4 Smiths Medical ASD Inc. II Feb-01-2018
5 Smiths Medical ASD, Inc. II Mar-10-2017
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