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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
MEQU A/S
  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 1033 1033
2024 756 757

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 1307 1307
Leak/Splash 519 519
Device Alarm System 513 513
Temperature Problem 404 404
Display or Visual Feedback Problem 284 284
Crack 244 244
Break 217 217
Power Problem 180 180
Defective Alarm 173 173
Insufficient Heating 167 167
No Audible Alarm 164 164
Mechanical Problem 163 163
Overheating of Device 129 129
False Alarm 114 114
Electrical /Electronic Property Problem 112 112
Fracture 108 108
Failure to Power Up 107 107
Defective Component 107 107
Noise, Audible 95 95
Excessive Heating 89 89
Failure to Pump 86 86
No Display/Image 85 85
Pumping Problem 71 71
Connection Problem 66 66
Failure to Calibrate 58 58
Infusion or Flow Problem 53 53
Device Sensing Problem 48 48
Defective Device 48 48
Display Difficult to Read 45 45
Material Separation 45 45
Pressure Problem 42 42
Component Missing 40 40
Key or Button Unresponsive/not Working 39 39
Output Problem 38 38
Detachment of Device or Device Component 37 38
Calibration Problem 37 37
Audible Prompt/Feedback Problem 36 36
Device Damaged Prior to Use 36 36
Improper Flow or Infusion 35 35
Alarm Not Visible 30 30
Patient Device Interaction Problem 30 30
Insufficient Flow or Under Infusion 30 30
Smoking 29 29
Failure to Sense 29 29
Circuit Failure 29 29
No Flow 28 28
Incorrect, Inadequate or Imprecise Result or Readings 28 28
Insufficient Information 26 26
Failure to Deliver 24 24
Erratic or Intermittent Display 22 22

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3179 3180
Insufficient Information 1232 1232
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
Hypovolemic Shock 5 5
Death 5 5
Patient Problem/Medical Problem 4 4
Urethral Stenosis/Stricture 3 3
Exsanguination 3 3
Hemorrhage/Bleeding 2 2
Aneurysm 2 2
Bruise/Contusion 2 2
Hypothermia 2 2
Ischemia 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Ruptured Aneurysm 2 2
Thrombosis/Thrombus 1 1
Missing Value Reason 1 1
Not Applicable 1 1
Skin Inflammation/ Irritation 1 1
Hypovolemia 1 1
Electric Shock 1 1
Burn(s) 1 1
Cardiac Arrest 1 1
Infiltration into Tissue 1 1
Exposure to Body Fluids 1 1
Abrasion 1 1
Adhesion(s) 1 1
Hemothorax 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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