• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
SMITHS MEDICAL ADS, 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 2331 2331
2021 3131 3131

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 2856 2856
Break 2461 2461
Device Markings/Labelling Problem 2004 2004
Corroded 1267 1267
Appropriate Term/Code Not Available 977 977
Deformation Due to Compressive Stress 835 835
Contamination 512 512
No Apparent Adverse Event 511 511
Computer Software Problem 495 495
Failure to Align 466 466
Naturally Worn 430 430
Device Sensing Problem 321 321
Misassembled 315 315
Degraded 239 239
Excess Flow or Over-Infusion 195 195
Physical Resistance/Sticking 182 182
Circuit Failure 171 171
Failure to Calibrate 134 134
Infusion or Flow Problem 130 130
Display or Visual Feedback Problem 130 130
Failure to Analyze Signal 124 124
Insufficient Information 117 117
Inaccurate Delivery 103 103
Insufficient Flow or Under Infusion 103 103
Failure to Read Input Signal 92 92
Device Alarm System 90 90
Device Displays Incorrect Message 71 71
Calibration Problem 71 71
Volume Accuracy Problem 64 64
Display Difficult to Read 61 61
Application Program Freezes, Becomes Nonfunctional 45 45
Electrical /Electronic Property Problem 30 30
Communication or Transmission Problem 28 28
Pumping Stopped 24 24
Failure to Power Up 21 21
Fluid Leak 18 18
Inaccurate Flow Rate 16 16
Improper Flow or Infusion 15 15
Application Program Problem 14 14
Battery Problem 14 14
Mechanics Altered 13 13
Audible Prompt/Feedback Problem 13 13
Output Problem 12 12
Use of Device Problem 12 12
Adverse Event Without Identified Device or Use Problem 11 11
Improper or Incorrect Procedure or Method 10 10
Failure to Infuse 10 10
No Display/Image 10 10
Failure to Cycle 10 10
False Alarm 10 10
Device Operates Differently Than Expected 9 9
Missing Information 9 9
Loose or Intermittent Connection 8 8
Device Slipped 8 8
Occlusion Within Device 7 7
Component Missing 7 7
Pressure Problem 7 7
Noise, Audible 6 6
Connection Problem 6 6
Application Program Version or Upgrade Problem 6 6
Fail-Safe Problem 6 6
Leak/Splash 6 6
Nonstandard Device 5 5
Increase in Pressure 5 5
Charred 5 5
Protective Measures Problem 5 5
Contamination /Decontamination Problem 5 5
Failure to Deliver 5 5
Loss of Power 5 5
Incorrect, Inadequate or Imprecise Resultor Readings 4 4
No Audible Prompt/Feedback 4 4
No Flow 4 4
Device Contamination with Chemical or Other Material 4 4
Defective Alarm 4 4
Material Discolored 4 4
Application Program Problem: Medication Error 4 4
Complete Loss of Power 4 4
Programming Issue 3 3
Filling Problem 3 3
Failure to Charge 3 3
Smoking 3 3
Lack of Maintenance Documentation or Guidelines 3 3
Device Inoperable 3 3
Computer System Security Problem 3 3
Charging Problem 2 2
Application Security Problem 2 2
Biocompatibility 2 2
Date/Time-Related Software Problem 2 2
Defective Device 2 2
Device Damaged Prior to Use 2 2
Obstruction of Flow 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Integrity Problem 2 2
Pumping Problem 2 2
Inaccurate Dispensing 2 2
Delivery System Failure 2 2
Difficult to Open or Close 2 2
Inaccurate Synchronization 2 2
Failure to Sense 2 2
Product Quality Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 3481 3481
No Clinical Signs, Symptoms or Conditions 2014 2014
No Consequences Or Impact To Patient 205 206
No Known Impact Or Consequence To Patient 196 196
No Information 166 166
Insufficient Information 86 86
Pain 14 14
Overdose 13 13
Not Applicable 13 13
Death 8 8
Cardiac Arrest 5 5
Low Blood Pressure/ Hypotension 4 4
Oversedation 4 4
Dizziness 4 4
Low Oxygen Saturation 4 4
Underdose 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
High Blood Pressure/ Hypertension 3 3
Anxiety 2 2
Decreased Respiratory Rate 2 2
Inadequate Pain Relief 2 2
Coma 2 2
Nausea 2 2
Respiratory Distress 2 2
No Code Available 2 2
Decreased Sensitivity 1 1
Patient Problem/Medical Problem 1 1
Shock 1 1
Tachycardia 1 1
Blurred Vision 1 1
Vomiting 1 1
Neurological Deficit/Dysfunction 1 1
Hypoxia 1 1
Ischemia 1 1
Cardiopulmonary Arrest 1 1
Aneurysm 1 1
Bradycardia 1 1
Dyspnea 1 1
Fatigue 1 1
Gastritis 1 1
Diaphoresis 1 1
Chest Tightness/Pressure 1 1
Pallor 1 1
Brain Injury 1 1
Convulsion, Clonic 1 1
Complaint, Ill-Defined 1 1
Injury 1 1
Hypoesthesia 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
-
-