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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device heat-exchanger, cardiopulmonary bypass
Product CodeDTR
Regulation Number 870.4240
Device Class 2


Premarket Reviews
ManufacturerDecision
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CARDIOPULMONARY AG
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
QUARA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
QUEST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
QURA S.R.L.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 66 66
2015 96 96
2016 60 60
2017 69 69
2018 75 75
2019 35 35
2020 33 33
2021 11 11
2022 23 23
2023 19 19
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 132 132
Device Displays Incorrect Message 113 113
Leak/Splash 86 86
Device Operates Differently Than Expected 38 38
Device Sensing Problem 17 17
Other (for use when an appropriate device code cannot be identified) 15 15
Loss of Power 14 14
Air Leak 12 12
Failure to Deliver 12 12
No Apparent Adverse Event 12 12
Device Contamination with Chemical or Other Material 10 10
Adverse Event Without Identified Device or Use Problem 10 10
Failure to Prime 10 10
Defective Device 9 9
Difficult to Open or Close 9 9
Appropriate Term/Code Not Available 7 7
Solder Joint Fracture 7 7
Nonstandard Device 7 7
Insufficient Information 6 6
Gas/Air Leak 6 6
Infusion or Flow Problem 6 6
Air/Gas in Device 5 5
Mechanical Problem 5 5
Display or Visual Feedback Problem 5 5
Defective Component 5 5
Detachment Of Device Component 4 4
Moisture Damage 4 4
Device Emits Odor 4 4
Noise, Audible 4 4
No Flow 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Improper Flow or Infusion 3 3
Unintended Movement 3 3
Pressure Problem 3 3
Particulates 3 3
Excess Flow or Over-Infusion 3 3
Increase in Pressure 3 3
Loss of or Failure to Bond 3 3
Burst Container or Vessel 3 3
Component Missing 3 3
Inaccurate Delivery 3 3
Connection Problem 3 3
Material Puncture/Hole 3 3
Self-Activation or Keying 3 3
Sticking 3 3
Device Inoperable 3 3
Use of Device Problem 3 3
Device Stops Intermittently 2 2
Visual Prompts will not Clear 2 2
Material Rupture 2 2
Insufficient Flow or Under Infusion 2 2
Material Separation 2 2
Application Program Problem 2 2
Device Issue 2 2
Device Contamination with Body Fluid 2 2
Device Alarm System 2 2
Electromagnetic Interference 2 2
Intermittent Continuity 2 2
Failure to Power Up 2 2
Decrease in Pressure 2 2
Occlusion Within Device 2 2
No Display/Image 2 2
Hole In Material 2 2
Protective Measures Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Output Problem 2 2
Positioning Problem 2 2
Complete Loss of Power 2 2
Material Split, Cut or Torn 1 1
Power Problem 1 1
Data Problem 1 1
No Pressure 1 1
Material Integrity Problem 1 1
Material Protrusion/Extrusion 1 1
Mechanics Altered 1 1
Device Contaminated During Manufacture or Shipping 1 1
Improper Device Output 1 1
Device Dislodged or Dislocated 1 1
Electronic Property Issue 1 1
Failure of Device to Self-Test 1 1
Foreign material 1 1
Loose or Intermittent Connection 1 1
Insufficient Cooling 1 1
Crack 1 1
Decoupling 1 1
Degraded 1 1
Electrical /Electronic Property Problem 1 1
Contamination 1 1
Defective Alarm 1 1
Failure To Adhere Or Bond 1 1
Backflow 1 1
Circuit Failure 1 1
Break 1 1
Microbial Contamination of Device 1 1
Obstruction of Flow 1 1
Split 1 1
Failure to Infuse 1 1
Detachment of Device or Device Component 1 1
Device Contamination With Biological Material 1 1
Device Operational Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 192 192
No Known Impact Or Consequence To Patient 168 168
No Clinical Signs, Symptoms or Conditions 52 52
No Patient Involvement 23 23
Blood Loss 22 22
No Information 9 9
Insufficient Information 7 7
No Patient involvement 7 7
Bacterial Infection 7 7
Fever 4 4
Renal Failure 3 3
Electrolyte Imbalance 3 3
Underdose 2 2
Malaise 2 2
Hemorrhage/Bleeding 2 2
Unspecified Infection 2 2
Overdose 2 2
Cardiac Arrest 2 2
Death 2 2
Endocarditis 2 2
Not Applicable 2 2
No Code Available 1 1
Fatigue 1 1
Sweating 1 1
Irregular Pulse 1 1
Respiratory Failure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Maquet Cardiovascular Us Sales, Llc II Mar-10-2014
2 Maquet Medical Systems USA II May-26-2023
3 Quest Medical, Inc III Apr-08-2011
4 Quest Medical, Inc. II May-22-2020
5 Quest Medical, Inc. II Dec-02-2015
6 Terumo Cardiovascular Corporation II Sep-29-2010
7 Terumo Cardiovascular Systems Corp II Oct-31-2014
8 Terumo Cardiovascular Systems Corp II Aug-02-2010
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