Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device heat-exchanger, cardiopulmonary bypass
Product CodeDTR
Regulation Number 870.4240
Device Class 2


Premarket Reviews
ManufacturerDecision
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
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 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 93 93
Fluid/Blood Leak 63 63
Leak/Splash 28 28
Device Operates Differently Than Expected 27 27
Device Sensing Problem 17 17
Loss of Power 11 11
No Apparent Adverse Event 11 11
Air Leak 9 9
Adverse Event Without Identified Device or Use Problem 9 9
Defective Device 8 8
Failure to Deliver 8 8
Solder Joint Fracture 7 7
Appropriate Term/Code Not Available 7 7
Gas/Air Leak 6 6
Device Contamination with Chemical or Other Material 6 6
Insufficient Information 5 5
Air/Gas in Device 5 5
Defective Component 5 5
Infusion or Flow Problem 5 5
Difficult to Open or Close 5 5
Detachment Of Device Component 4 4
Moisture Damage 4 4
Device Emits Odor 4 4
Loss of or Failure to Bond 3 3
Inaccurate Delivery 3 3
Noise, Audible 3 3
Failure to Prime 3 3
Sticking 3 3
Self-Activation or Keying 3 3
Particulates 3 3
Display or Visual Feedback Problem 3 3
No Flow 3 3
Mechanical Problem 3 3
Material Puncture/Hole 3 3
Unintended Movement 3 3
Use of Device Problem 3 3
Improper Flow or Infusion 3 3
Pressure Problem 3 3
Device Stops Intermittently 2 2
Connection Problem 2 2
Intermittent Continuity 2 2
Complete Loss of Power 2 2
Electromagnetic Interference 2 2
Device Contamination with Body Fluid 2 2
No Display/Image 2 2
Hole In Material 2 2
Visual Prompts will not Clear 2 2
Failure to Power Up 2 2
Increase in Pressure 2 2
Protective Measures Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 156 156
No Known Impact Or Consequence To Patient 81 81
No Clinical Signs, Symptoms or Conditions 53 53
Blood Loss 15 15
No Patient Involvement 11 11
Insufficient Information 7 7
Bacterial Infection 6 6
Fever 4 4
Electrolyte Imbalance 3 3
Renal Failure 3 3
Unspecified Infection 2 2
Death 2 2
Malaise 2 2
Overdose 2 2
Endocarditis 2 2
Sweating 1 1
Fatigue 1 1
Not Applicable 1 1
No Code Available 1 1
No Information 1 1
Cardiac Arrest 1 1
Hemorrhage/Bleeding 1 1
Respiratory Failure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Maquet Medical Systems USA II May-26-2023
2 Quest Medical, Inc. II May-22-2020
-
-