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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pump, blood, cardiopulmonary bypass, non-roller type
Regulation Description Nonroller-type blood pump.
Product CodeKFM
Regulation Number 870.4360
Device Class 2


Premarket Reviews
ManufacturerDecision
CARDIACASSIST, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL BIOPHYSICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
QURA S.R.L
  SUBSTANTIALLY EQUIVALENT 1
QURA S.R.L.
  SUBSTANTIALLY EQUIVALENT 4
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 438 438
2021 446 446
2022 294 294
2023 350 350
2024 309 309
2025 33 33

Device Problems MDRs with this Device Problem Events in those MDRs
Electrical /Electronic Property Problem 434 434
Insufficient Information 233 233
Pumping Stopped 174 174
Adverse Event Without Identified Device or Use Problem 149 149
Noise, Audible 128 128
Infusion or Flow Problem 123 123
Mechanical Problem 113 113
Device Displays Incorrect Message 107 107
Battery Problem 77 77
Unexpected Shutdown 76 76
Overheating of Device 64 64
Inaccurate Flow Rate 46 46
Pumping Problem 35 35
Communication or Transmission Problem 27 27
Fluid/Blood Leak 22 22
Insufficient Flow or Under Infusion 18 18
No Apparent Adverse Event 18 18
Increased Pump Speed 18 18
Device Difficult to Setup or Prepare 17 17
Decreased Pump Speed 17 17
No Flow 17 17
Excessive Heating 12 12
Break 12 12
Obstruction of Flow 12 12
Leak/Splash 11 11
Display or Visual Feedback Problem 11 11
Detachment of Device or Device Component 10 10
No Display/Image 10 10
Material Twisted/Bent 9 9
Premature Discharge of Battery 8 8
Failure to Power Up 8 8
Crack 8 8
Failure to Pump 8 8
Use of Device Problem 8 8
Product Quality Problem 7 7
Electrical Power Problem 7 7
Material Deformation 7 7
Improper Flow or Infusion 7 7
Fracture 6 6
Loose or Intermittent Connection 6 6
Unexpected Therapeutic Results 6 6
Disconnection 6 6
Gas/Air Leak 5 5
Material Puncture/Hole 5 5
Image Display Error/Artifact 4 4
Device Alarm System 4 4
Fitting Problem 4 4
Labelling, Instructions for Use or Training Problem 4 4
Pressure Problem 4 4
Device Sensing Problem 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1186 1186
No Consequences Or Impact To Patient 190 190
No Patient Involvement 140 140
Insufficient Information 105 105
No Known Impact Or Consequence To Patient 81 81
Hemorrhage/Bleeding 65 65
Thrombosis/Thrombus 45 45
Hemolysis 30 30
Cardiac Arrest 28 28
Heart Failure/Congestive Heart Failure 28 28
Death 24 24
Bacterial Infection 20 20
Low Oxygen Saturation 19 19
Arrhythmia 16 16
Multiple Organ Failure 16 16
No Information 16 16
Renal Failure 15 15
Ischemia Stroke 14 14
Thromboembolism 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Sepsis 11 11
Hypoxia 11 11
Unspecified Infection 10 10
Respiratory Failure 10 10
Tachycardia 10 10
Stroke/CVA 10 10
Cardiogenic Shock 9 9
Low Blood Pressure/ Hypotension 9 9
Atrial Fibrillation 9 9
Renal Impairment 8 8
Blood Loss 8 8
Fungal Infection 7 7
Thrombus 7 7
Gastrointestinal Hemorrhage 5 5
Hemorrhagic Stroke 5 5
Intracranial Hemorrhage 5 5
Anemia 5 5
Hematoma 5 5
Ventricular Fibrillation 4 4
Bradycardia 4 4
Air Embolism 4 4
Respiratory Insufficiency 4 4
Lactate Dehydrogenase Increased 4 4
Brain Injury 4 4
Ischemia 4 4
Septic Shock 3 3
Encephalopathy 3 3
Obstruction/Occlusion 3 3
Hematuria 3 3
Hypovolemia 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Cardiac Assist, Inc II Aug-25-2023
2 Cardiac Assist, Inc II May-11-2020
3 Maquet Cardiovascular Us Sales, Llc III Sep-12-2020
4 Maquet Medical Systems USA II Feb-02-2024
5 OriGen Biomedical, Inc. II Oct-30-2020
6 QURA S.R.L. II Aug-12-2021
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