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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
Product CodeLGZ
Regulation Number 880.5725
Device Class 2


Premarket Reviews
ManufacturerDecision
BARKEY GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
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 840 840
2022 823 823

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 724 724
Leak/Splash 370 370
Device Alarm System 331 331
Temperature Problem 286 286
Display or Visual Feedback Problem 163 163
Crack 138 138
Power Problem 126 126
No Audible Alarm 102 102
Break 86 86
Mechanical Problem 82 82
Defective Alarm 77 77
Excessive Heating 73 73
Electrical /Electronic Property Problem 72 72
Overheating of Device 67 67
False Alarm 66 66
Insufficient Heating 65 65
Failure to Power Up 58 58
Infusion or Flow Problem 51 51
Defective Component 46 46
Pumping Problem 45 45
Pressure Problem 44 44
Noise, Audible 43 43
No Display/Image 42 42
Failure to Calibrate 35 35
Output Problem 32 32
Smoking 29 29
Insufficient Flow or Under Infusion 28 28
Display Difficult to Read 28 28
Improper Flow or Infusion 28 28
Connection Problem 27 27
Calibration Problem 26 26
Material Separation 24 24
Defective Device 21 21
Failure to Pump 20 20
Device Damaged Prior to Use 20 20
Component Missing 18 18
Device Displays Incorrect Message 18 18
Device Sensing Problem 18 18
Erratic or Intermittent Display 18 18
Circuit Failure 18 18
Appropriate Term/Code Not Available 16 16
Disconnection 14 14
Device Emits Odor 14 14
Increase in Pressure 13 13
No Flow 13 13
No Visual Prompts/Feedback 13 13
Naturally Worn 12 12
Fire 12 12
Image Display Error/Artifact 11 11
Fracture 11 11
Insufficient Information 11 11
Complete Loss of Power 11 11
Intermittent Loss of Power 10 10
Audible Prompt/Feedback Problem 10 10
No Tactile Prompts/Feedback 10 10
Failure of Device to Self-Test 10 10
Contamination /Decontamination Problem 10 10
Failure to Sense 9 9
Contamination 9 9
Material Twisted/Bent 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Protective Measures Problem 8 8
No Apparent Adverse Event 8 8
Thermal Decomposition of Device 8 8
Material Fragmentation 8 8
Grounding Malfunction 8 8
Fitting Problem 8 8
Failure to Infuse 8 8
Obstruction of Flow 7 7
No Audible Prompt/Feedback 7 7
Particulates 7 7
Loose or Intermittent Connection 7 7
Alarm Not Visible 7 7
Device Fell 7 7
Material Integrity Problem 7 7
Material Deformation 6 6
Failure to Conduct 6 6
Sparking 6 6
Electrical Power Problem 6 6
Electrical Shorting 6 6
Device Operates Differently Than Expected 6 6
Electrical Overstress 5 5
Detachment of Device or Device Component 5 5
Flare or Flash 5 5
Device Contamination with Chemical or Other Material 5 5
Use of Device Problem 5 5
Inaccurate Flow Rate 5 5
Loss of Power 5 5
Failure to Prime 4 4
Poor Quality Image 4 4
Melted 4 4
Inflation Problem 4 4
Corroded 4 4
Material Discolored 4 4
Unable to Obtain Readings 4 4
Incorrect, Inadequate or Imprecise Resultor Readings 4 4
Air/Gas in Device 4 4
Key or Button Unresponsive/not Working 4 4
Human-Device Interface Problem 3 3
Mechanical Jam 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1214 1214
No Information 757 757
No Patient Involvement 518 518
Insufficient Information 372 372
No Known Impact Or Consequence To Patient 329 329
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
Ruptured Aneurysm 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Thrombosis/Thrombus 1 1
Urethral Stenosis/Stricture 1 1
Missing Value Reason 1 1
Superficial (First Degree) Burn 1 1
Partial thickness (Second Degree) Burn 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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