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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 2
SMISSON-CARTLEDGE BIOMEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
THE SURGICAL COMPANY INTERNATIONAL B.V.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 94 94
2019 340 340
2020 1221 1221
2021 884 884
2022 1548 1548
2023 709 709

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 1001 1001
Leak/Splash 505 505
Device Alarm System 424 424
Temperature Problem 361 361
Display or Visual Feedback Problem 239 239
Crack 187 187
Break 173 173
Power Problem 164 164
Mechanical Problem 158 158
No Audible Alarm 129 129
Defective Alarm 124 124
Overheating of Device 114 114
Insufficient Heating 111 111
Electrical /Electronic Property Problem 97 97
False Alarm 90 90
Failure to Power Up 88 88
Defective Component 85 85
Excessive Heating 85 85
Noise, Audible 76 76
No Display/Image 75 75
Fracture 64 64
Pumping Problem 64 64
Infusion or Flow Problem 52 52
Connection Problem 52 52
Failure to Pump 49 49
Failure to Calibrate 46 46
Pressure Problem 43 43
Defective Device 40 40
Display Difficult to Read 39 39
Device Sensing Problem 37 37
Output Problem 37 37
Improper Flow or Infusion 35 35
Audible Prompt/Feedback Problem 34 34
Calibration Problem 34 34
Material Separation 33 33
Device Damaged Prior to Use 33 33
Smoking 30 30
Insufficient Flow or Under Infusion 30 30
Patient Device Interaction Problem 30 30
Component Missing 29 29
Circuit Failure 29 29
Device Displays Incorrect Message 23 23
Failure to Deliver 20 20
Erratic or Intermittent Display 20 20
Detachment of Device or Device Component 19 19
Insufficient Information 18 18
No Flow 17 17
Appropriate Term/Code Not Available 16 16
Key or Button Unresponsive/not Working 16 16
Failure to Sense 16 16
Increase in Pressure 15 15
Alarm Not Visible 15 15
No Visual Prompts/Feedback 14 14
Material Twisted/Bent 13 13
Naturally Worn 13 13
Corroded 13 13
Fire 13 13
Image Display Error/Artifact 13 13
Device Emits Odor 13 13
Fitting Problem 12 12
Incorrect, Inadequate or Imprecise Result or Readings 11 11
Contamination /Decontamination Problem 11 11
Material Fragmentation 11 11
Complete Loss of Power 11 11
Intermittent Loss of Power 11 11
No Tactile Prompts/Feedback 10 10
Failure of Device to Self-Test 10 10
Grounding Malfunction 10 10
Contamination 10 10
Obstruction of Flow 10 10
Use of Device Problem 10 10
No Audible Prompt/Feedback 10 10
Device Difficult to Setup or Prepare 9 9
Electrical Power Problem 9 9
Device Fell 9 9
Air/Gas in Device 9 9
No Apparent Adverse Event 9 9
Electrical Shorting 8 8
Protective Measures Problem 8 8
Material Integrity Problem 8 8
Adverse Event Without Identified Device or Use Problem 8 8
Loose or Intermittent Connection 8 8
Thermal Decomposition of Device 8 8
Failure to Infuse 8 8
Sparking 7 7
Deformation Due to Compressive Stress 7 7
Unable to Obtain Readings 7 7
Failure to Conduct 7 7
Disconnection 7 7
Poor Quality Image 7 7
Particulates 7 7
Manufacturing, Packaging or Shipping Problem 7 7
Material Deformation 7 7
Material Split, Cut or Torn 7 7
Flare or Flash 6 6
Inaccurate Flow Rate 6 6
Degraded 6 6
Material Discolored 5 5
Loss of Power 5 5
Electrical Overstress 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2332 2332
Insufficient Information 915 915
No Information 756 756
No Patient Involvement 514 514
No Consequences Or Impact To Patient 312 312
No Known Impact Or Consequence To Patient 287 287
No Code Available 6 6
Death 6 6
Hypovolemic Shock 4 4
Patient Problem/Medical Problem 4 4
Urethral Stenosis/Stricture 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Hypothermia 2 2
Ruptured Aneurysm 2 2
Ischemia 2 2
Injury 2 2
Electric Shock 2 2
Exsanguination 2 2
Hemorrhage/Bleeding 2 2
Aneurysm 2 2
Bruise/Contusion 2 2
Cardiac Arrest 2 2
Adhesion(s) 1 1
Burn(s) 1 1
Low Blood Pressure/ Hypotension 1 1
Superficial (First Degree) Burn 1 1
Shock 1 1
Unspecified Infection 1 1
Infiltration into Tissue 1 1
Thrombosis/Thrombus 1 1
Missing Value Reason 1 1
Not Applicable 1 1
Skin Inflammation/ Irritation 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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