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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
Regulation Description Infusion pump.
Product CodeLGZ
Regulation Number 880.5725
Device Class 2


Premarket Reviews
ManufacturerDecision
BARKEY GMBH & CO. KG
  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
2020 1221 1221
2021 885 885
2022 1548 1548
2023 1033 1033
2024 862 863
2025 196 196

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 1322 1322
Leak/Splash 469 469
Device Alarm System 469 469
Temperature Problem 383 383
Display or Visual Feedback Problem 285 285
Crack 225 225
Break 216 216
Insufficient Heating 205 205
Power Problem 179 179
Defective Alarm 161 161
Mechanical Problem 160 160
No Audible Alarm 144 144
Overheating of Device 138 138
Fracture 111 111
Electrical /Electronic Property Problem 110 110
Failure to Power Up 110 110
Defective Component 109 109
Failure to Pump 108 108
Noise, Audible 95 95
Excessive Heating 92 92
No Display/Image 84 84
False Alarm 80 80
Pumping Problem 73 73
Connection Problem 69 69
Failure to Calibrate 60 60
Device Sensing Problem 50 50
Infusion or Flow Problem 50 50
Defective Device 47 47
Material Separation 46 46
Display Difficult to Read 45 45
Key or Button Unresponsive/not Working 43 43
Pressure Problem 42 42
Failure to Sense 40 40
Detachment of Device or Device Component 37 38
Device Damaged Prior to Use 36 36
Audible Prompt/Feedback Problem 35 35
Component Missing 34 34
Output Problem 34 34
Improper Flow or Infusion 33 33
No Flow 33 33
Calibration Problem 33 33
Circuit Failure 32 32
Incorrect, Inadequate or Imprecise Result or Readings 31 31
Patient Device Interaction Problem 30 30
Failure to Deliver 28 28
Alarm Not Visible 27 27
Insufficient Information 27 27
Insufficient Flow or Under Infusion 26 26
Air/Gas in Device 25 25
Erratic or Intermittent Display 22 22

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3463 3464
Insufficient Information 1243 1243
No Information 661 661
No Patient Involvement 444 444
No Consequences Or Impact To Patient 258 258
No Known Impact Or Consequence To Patient 61 61
Hypovolemic Shock 5 5
Thrombosis/Thrombus 5 5
Death 4 4
Exsanguination 4 4
Patient Problem/Medical Problem 3 3
Urethral Stenosis/Stricture 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Code Available 2 2
Ischemia 2 2
Cardiac Arrest 2 2
Hypothermia 2 2
Aneurysm 2 2
Ruptured Aneurysm 2 2
Hemorrhage/Bleeding 2 2
Electric Shock 1 1
Not Applicable 1 1
Respiratory Arrest 1 1
Skin Inflammation/ Irritation 1 1
Adhesion(s) 1 1
Abrasion 1 1
Anaphylactoid 1 1
Obstruction/Occlusion 1 1
Burn(s) 1 1
Exposure to Body Fluids 1 1
Missing Value Reason 1 1
Hemothorax 1 1
Bruise/Contusion 1 1
Hypovolemia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Belmont Instrument LLC II Apr-25-2025
2 Belmont Instrument LLC II Apr-25-2025
3 Eight Medical International BV I Jul-23-2021
4 RanD S.r.l. II Jul-09-2021
5 Smisson-Cartledge Biomedical, LLC I Mar-26-2021
6 Smiths Medical ASD Inc. I Sep-03-2021
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