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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 885 885
2022 1548 1548
2023 1032 1032
2024 424 424

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 1202 1202
Leak/Splash 511 511
Device Alarm System 487 487
Temperature Problem 378 378
Display or Visual Feedback Problem 280 280
Crack 232 232
Break 209 209
Power Problem 177 177
Defective Alarm 160 160
Mechanical Problem 160 160
No Audible Alarm 159 159
Insufficient Heating 139 139
Overheating of Device 126 126
Electrical /Electronic Property Problem 111 111
Failure to Power Up 106 106
False Alarm 104 104
Defective Component 103 103
Fracture 99 99
Noise, Audible 94 94
No Display/Image 82 82
Excessive Heating 81 81
Failure to Pump 78 78
Pumping Problem 71 71
Connection Problem 63 63
Failure to Calibrate 57 57
Infusion or Flow Problem 52 52
Device Sensing Problem 46 46
Display Difficult to Read 45 45
Material Separation 44 44
Pressure Problem 42 42
Defective Device 41 41
Output Problem 38 38
Calibration Problem 37 37
Component Missing 37 37
Device Damaged Prior to Use 36 36
Detachment of Device or Device Component 36 36
Audible Prompt/Feedback Problem 36 36
Improper Flow or Infusion 35 35
Key or Button Unresponsive/not Working 33 33
Patient Device Interaction Problem 30 30
Insufficient Flow or Under Infusion 30 30
Alarm Not Visible 29 29
Circuit Failure 29 29
Smoking 28 28
Insufficient Information 26 26
No Flow 25 25
Incorrect, Inadequate or Imprecise Result or Readings 25 25
Failure to Sense 23 23
Failure to Deliver 23 23
Erratic or Intermittent Display 22 22
Corroded 20 20
Image Display Error/Artifact 16 16
Air/Gas in Device 16 16
Device Displays Incorrect Message 15 15
Increase in Pressure 15 15
Fitting Problem 15 15
No Visual Prompts/Feedback 14 14
Material Twisted/Bent 14 14
Naturally Worn 13 13
Intermittent Loss of Power 13 13
Contamination /Decontamination Problem 13 13
Contamination 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
Loose or Intermittent Connection 10 10
Disconnection 10 10
Fire 10 10
Electrical Power Problem 10 10
No Tactile Prompts/Feedback 10 10
Appropriate Term/Code Not Available 10 10
Device Fell 10 10
Device Difficult to Maintain 9 9
No Apparent Adverse Event 9 9
Electrical Shorting 9 9
Poor Quality Image 9 9
Device Emits Odor 9 9
Device Difficult to Setup or Prepare 9 9
Unable to Obtain Readings 8 8
Failure to Infuse 8 8
Electrical Overstress 8 8
Protective Measures Problem 8 8
Material Integrity Problem 8 8
Manufacturing, Packaging or Shipping Problem 7 7
Flare or Flash 7 7
Material Split, Cut or Torn 7 7
Low Readings 7 7
Deformation Due to Compressive Stress 7 7
Particulates 7 7
Material Discolored 7 7
Failure to Cycle 6 6
Degraded 6 6
Failure to Conduct 6 6
Inaccurate Flow Rate 6 6
Sparking 6 6
Device Contamination with Chemical or Other Material 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2869 2869
Insufficient Information 1210 1210
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
No Code Available 5 5
Death 5 5
Patient Problem/Medical Problem 4 4
Hypovolemic Shock 4 4
Urethral Stenosis/Stricture 3 3
Ruptured Aneurysm 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Ischemia 2 2
Exsanguination 2 2
Hemorrhage/Bleeding 2 2
Hypothermia 2 2
Aneurysm 2 2
Bruise/Contusion 2 2
Burn(s) 1 1
Cardiac Arrest 1 1
Infiltration into Tissue 1 1
Abrasion 1 1
Adhesion(s) 1 1
Electric Shock 1 1
Thrombosis/Thrombus 1 1
Skin Inflammation/ Irritation 1 1
Missing Value Reason 1 1
Not Applicable 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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