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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 1
SMISSON-CARTLEDGE BIOMEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
THE SURGICAL COMPANY INTERNATIONAL B.V.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 340 340
2020 1221 1221
2021 884 884
2022 1548 1548
2023 1032 1032
2024 95 95

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 1125 1125
Leak/Splash 504 504
Device Alarm System 457 457
Temperature Problem 369 369
Display or Visual Feedback Problem 257 257
Crack 209 209
Break 193 193
Power Problem 172 172
Mechanical Problem 160 160
No Audible Alarm 145 145
Defective Alarm 141 141
Insufficient Heating 126 126
Overheating of Device 121 121
Electrical /Electronic Property Problem 100 100
False Alarm 96 96
Failure to Power Up 95 95
Defective Component 95 95
Noise, Audible 87 87
Fracture 80 80
Excessive Heating 79 79
No Display/Image 77 77
Pumping Problem 68 68
Failure to Pump 65 65
Connection Problem 59 59
Failure to Calibrate 54 54
Infusion or Flow Problem 50 50
Material Separation 44 44
Device Sensing Problem 42 42
Display Difficult to Read 42 42
Pressure Problem 42 42
Defective Device 40 40
Output Problem 36 36
Audible Prompt/Feedback Problem 36 36
Improper Flow or Infusion 35 35
Calibration Problem 35 35
Component Missing 34 34
Device Damaged Prior to Use 33 33
Detachment of Device or Device Component 32 32
Insufficient Flow or Under Infusion 30 30
Patient Device Interaction Problem 30 30
Smoking 28 28
Circuit Failure 28 28
Alarm Not Visible 26 26
Key or Button Unresponsive/not Working 25 25
Insufficient Information 24 24
Failure to Deliver 23 23
Erratic or Intermittent Display 22 22
Failure to Sense 21 21
Corroded 20 20
No Flow 20 20
Incorrect, Inadequate or Imprecise Result or Readings 18 18
Increase in Pressure 15 15
Fitting Problem 15 15
Device Displays Incorrect Message 15 15
Image Display Error/Artifact 15 15
Air/Gas in Device 15 15
No Visual Prompts/Feedback 14 14
Intermittent Loss of Power 13 13
Material Twisted/Bent 13 13
Naturally Worn 13 13
Contamination /Decontamination Problem 13 13
Material Fragmentation 12 12
Complete Loss of Power 12 12
Failure of Device to Self-Test 11 11
Grounding Malfunction 11 11
Obstruction of Flow 11 11
Use of Device Problem 10 10
No Audible Prompt/Feedback 10 10
Contamination 10 10
Fire 10 10
No Tactile Prompts/Feedback 10 10
Appropriate Term/Code Not Available 10 10
No Apparent Adverse Event 9 9
Device Fell 9 9
Electrical Power Problem 9 9
Disconnection 9 9
Device Difficult to Setup or Prepare 9 9
Device Emits Odor 9 9
Loose or Intermittent Connection 8 8
Poor Quality Image 8 8
Unable to Obtain Readings 8 8
Failure to Infuse 8 8
Electrical Shorting 8 8
Protective Measures Problem 8 8
Material Integrity Problem 8 8
Device Difficult to Maintain 8 8
Material Split, Cut or Torn 7 7
Flare or Flash 7 7
Manufacturing, Packaging or Shipping Problem 7 7
Deformation Due to Compressive Stress 7 7
Electrical Overstress 7 7
Particulates 7 7
Material Discolored 6 6
Degraded 6 6
Inaccurate Flow Rate 6 6
Failure to Conduct 6 6
Sparking 6 6
Low Readings 6 6
Device Contamination with Chemical or Other Material 6 6
Material Deformation 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2614 2614
Insufficient Information 1127 1127
No Information 737 737
No Patient Involvement 510 510
No Consequences Or Impact To Patient 309 309
No Known Impact Or Consequence To Patient 218 218
Death 5 5
No Code Available 5 5
Hypovolemic Shock 4 4
Patient Problem/Medical Problem 4 4
Urethral Stenosis/Stricture 3 3
Hypothermia 2 2
Aneurysm 2 2
Hemorrhage/Bleeding 2 2
Bruise/Contusion 2 2
Exsanguination 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Ischemia 2 2
Ruptured Aneurysm 2 2
Adhesion(s) 1 1
Infiltration into Tissue 1 1
Not Applicable 1 1
Thrombosis/Thrombus 1 1
Burn(s) 1 1
Skin Inflammation/ Irritation 1 1
Electric Shock 1 1
Missing Value Reason 1 1
Cardiac Arrest 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Eight Medical International BV I Jul-23-2021
2 RanD S.r.l. II Jul-09-2021
3 Smisson-Cartledge Biomedical, LLC I Mar-26-2021
4 Smiths Medical ASD Inc. I Sep-03-2021
5 Vyaire Medical I Jun-26-2019
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