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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device warmer, thermal, infusion fluid
Regulation Description Infusion pump.
Product CodeLGZ
Regulation Number 880.5725
Device Class 2


Premarket Reviews
ManufacturerDecision
LIFE WARMER, INC.
  SUBSTANTIALLY EQUIVALENT 2
MAC MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
QUALITY IN FLOW LTD.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2017 58 58
2018 95 95
2019 337 337
2020 1221 1221
2021 831 831

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 546 546
Device Alarm System 290 290
Leak/Splash 268 268
Temperature Problem 252 252
Display or Visual Feedback Problem 118 118
Crack 111 111
Power Problem 101 101
No Audible Alarm 82 82
Electrical /Electronic Property Problem 65 65
Mechanical Problem 65 65
Break 61 61
Excessive Heating 60 60
False Alarm 51 51
Infusion or Flow Problem 48 48
Overheating of Device 45 45
Pressure Problem 42 42
Failure to Power Up 41 41
Defective Alarm 33 33
Insufficient Heating 31 31
Output Problem 30 30
Defective Component 29 29
Pumping Problem 26 26
Insufficient Flow or Under Infusion 25 25
Improper Flow or Infusion 24 24
Smoking 23 23
Noise, Audible 23 23
Connection Problem 22 22
Display Difficult to Read 21 21
Material Separation 20 20
Calibration Problem 19 19
Device Displays Incorrect Message 18 18
Failure to Calibrate 16 16
Appropriate Term/Code Not Available 16 16
Circuit Failure 14 14
Disconnection 13 13
Erratic or Intermittent Display 13 13
No Display/Image 13 13
Increase in Pressure 13 13
Device Sensing Problem 13 13
Component Missing 12 12
No Visual Prompts/Feedback 12 12
Naturally Worn 12 12
No Flow 11 11
Device Damaged Prior to Use 11 11
Device Emits Odor 11 11
Failure to Pump 10 10
Fire 10 10
Complete Loss of Power 10 10
Intermittent Loss of Power 9 9
Insufficient Information 9 9
No Tactile Prompts/Feedback 9 9
Fracture 9 9
Contamination 9 9
Image Display Error/Artifact 9 9
Failure to Sense 9 9
Defective Device 8 8
Contamination /Decontamination Problem 8 8
Material Fragmentation 8 8
Adverse Event Without Identified Device or Use Problem 8 8
No Apparent Adverse Event 8 8
Audible Prompt/Feedback Problem 7 7
Thermal Decomposition of Device 7 7
Particulates 7 7
Material Integrity Problem 7 7
Material Twisted/Bent 7 7
Failure of Device to Self-Test 7 7
Obstruction of Flow 7 7
Failure to Infuse 7 7
Device Operates Differently Than Expected 6 6
Grounding Malfunction 6 6
Loose or Intermittent Connection 6 6
Alarm Not Visible 6 6
Failure to Conduct 6 6
Protective Measures Problem 6 6
Loss of Power 5 5
Detachment of Device or Device Component 5 5
Flare or Flash 5 5
Electrical Power Problem 5 5
Sparking 5 5
Use of Device Problem 4 4
Device Contamination with Chemical or Other Material 4 4
Electrical Overstress 4 4
Failure to Prime 4 4
Unable to Obtain Readings 4 4
Melted 4 4
Inflation Problem 4 4
Material Discolored 4 4
Material Deformation 4 4
Device Fell 4 4
Air/Gas in Device 4 4
Material Split, Cut or Torn 3 3
Restricted Flow rate 3 3
Signal Artifact/Noise 3 3
Misconnection 3 3
Pumping Stopped 3 3
Decrease in Pressure 3 3
Battery Problem 3 3
Failure to Shut Off 3 3
Mechanical Jam 3 3
Device Contaminated During Manufacture or Shipping 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 757 757
No Patient Involvement 518 518
No Clinical Signs, Symptoms or Conditions 419 419
No Known Impact Or Consequence To Patient 329 329
Insufficient Information 321 321
No Consequences Or Impact To Patient 315 315
Death 7 7
No Code Available 6 6
Patient Problem/Medical Problem 4 4
Hypothermia 3 3
Hypovolemic Shock 2 2
Injury 2 2
Exsanguination 2 2
Hemorrhage/Bleeding 2 2
Aneurysm 2 2
Bruise/Contusion 2 2
Cardiac Arrest 2 2
Not Applicable 2 2
Low Blood Pressure/ Hypotension 2 2
Electric Shock 2 2
Superficial (First Degree) Burn 1 1
Partial thickness (Second Degree) Burn 1 1
Missing Value Reason 1 1
Ruptured Aneurysm 1 1
Thrombosis/Thrombus 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Adhesion(s) 1 1
Burn(s) 1 1
Hypoglycemia 1 1
Low Oxygen Saturation 1 1
Complaint, Ill-Defined 1 1
Unspecified Infection 1 1
Infiltration into Tissue 1 1
Shock 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Eight Medical International BV I Jul-23-2021
2 Natus Manufacturing Limited II Jan-06-2017
3 RanD S.r.l. II Jul-09-2021
4 Smisson-Cartledge Biomedical, LLC I Mar-26-2021
5 Smiths Medical ASD Inc. I Sep-03-2021
6 Smiths Medical ASD, Inc. III Feb-07-2017
7 Vyaire Medical I Jun-26-2019
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