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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device controller, temperature, cardiopulmonary bypass
Definition If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product CodeDWC
Regulation Number 870.4250
Device Class 2


Premarket Reviews
ManufacturerDecision
LIVANOVA DEUTSCHLAND GMBH
  SUBSTANTIALLY EQUIVALENT 2
SPECTRUM MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 566 566
2019 697 697
2020 548 548
2021 622 622
2022 605 605

Device Problems MDRs with this Device Problem Events in those MDRs
Microbial Contamination of Device 1305 1305
Temperature Problem 254 254
Pumping Problem 221 221
Appropriate Term/Code Not Available 185 185
Electrical Shorting 165 165
Insufficient Cooling 135 135
Insufficient Heating 119 119
Fluid/Blood Leak 112 112
Device Displays Incorrect Message 99 99
Adverse Event Without Identified Device or Use Problem 51 51
Electrical /Electronic Property Problem 50 50
Smoking 43 43
Pumping Stopped 29 29
Infusion or Flow Problem 25 25
Device Emits Odor 24 24
Unexpected Shutdown 22 22
Contamination 21 21
Overheating of Device 20 20
Insufficient Information 20 20
No Flow 19 19
Failure to Pump 17 17
Noise, Audible 17 17
Device Alarm System 15 15
Biofilm coating in Device 13 13
Melted 13 13
Thermal Decomposition of Device 12 12
Device Operates Differently Than Expected 11 11
Mechanical Problem 10 10
Output Problem 9 9
Display or Visual Feedback Problem 9 9
Defective Component 9 9
Leak/Splash 9 9
Excessive Cooling 8 8
Loss of Power 8 8
Failure to Power Up 8 8
Device Issue 8 8
No Display/Image 8 8
Therapeutic or Diagnostic Output Failure 8 8
Defective Device 7 7
Break 7 7
Contamination /Decontamination Problem 7 7
Excessive Heating 7 7
Power Problem 6 6
Sparking 6 6
Circuit Failure 6 6
Use of Device Problem 6 6
Device Contamination with Chemical or Other Material 5 5
Device Sensing Problem 5 5
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Gas Output Problem 4 4
Electrical Power Problem 4 4
Self-Activation or Keying 3 3
Insufficient Flow or Under Infusion 3 3
Calibration Problem 3 3
Difficult to Open or Close 3 3
No Apparent Adverse Event 3 3
Arcing 3 3
Product Quality Problem 3 3
Failure of Device to Self-Test 3 3
Fail-Safe Did Not Operate 3 3
Gas/Air Leak 3 3
Intermittent Loss of Power 3 3
Material Fragmentation 2 2
Protective Measures Problem 2 2
Complete Blockage 2 2
Missing Information 2 2
Material Integrity Problem 2 2
Corroded 2 2
False Alarm 2 2
Ambient Temperature Problem 2 2
Device Contamination With Biological Material 2 2
Image Display Error/Artifact 2 2
Improper Flow or Infusion 2 2
Detachment of Device or Device Component 2 2
Blocked Connection 2 2
Incorrect Measurement 2 2
Complete Loss of Power 2 2
Key or Button Unresponsive/not Working 2 2
Device Damaged Prior to Use 1 1
Loose or Intermittent Connection 1 1
Material Rupture 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Restricted Flow rate 1 1
Erratic or Intermittent Display 1 1
Filling Problem 1 1
Crack 1 1
Degraded 1 1
No Audible Alarm 1 1
Device Abrasion From Instrument Or Another Object 1 1
Component Missing 1 1
Failure to Calibrate 1 1
Electrical Overstress 1 1
Naturally Worn 1 1
Radiation Output Problem 1 1
Activation Problem 1 1
Unintended Collision 1 1
Energy Output Problem 1 1
Alarm Not Visible 1 1
Partial Blockage 1 1
Material Discolored 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1034 1034
No Patient Involvement 705 705
No Known Impact Or Consequence To Patient 591 591
No Consequences Or Impact To Patient 348 348
Bacterial Infection 274 274
Death 47 47
Insufficient Information 26 26
Unspecified Infection 22 22
No Information 11 11
Fatigue 9 9
Fever 9 9
Alteration in Body Temperature 8 8
Endocarditis 8 8
Weight Changes 6 6
Abscess 4 4
Sepsis 4 4
Hypothermia 3 3
Post Operative Wound Infection 3 3
Weakness 3 3
Abdominal Pain 3 3
Multiple Organ Failure 3 3
Malaise 2 2
Dyspnea 2 2
No Code Available 2 2
Bradycardia 2 2
Alteration In Body Temperature 2 2
Pneumonia 2 2
High Blood Pressure/ Hypertension 2 2
Erythema 2 2
Fainting 1 1
Hepatitis 1 1
Anemia 1 1
Aortic Insufficiency 1 1
Cardiopulmonary Arrest 1 1
Non specific EKG/ECG Changes 1 1
Thrombus 1 1
Numbness 1 1
Sweating 1 1
Abdominal Distention 1 1
Unspecified Gastrointestinal Problem 1 1
Pneumothorax 1 1
Ventricular Fibrillation 1 1
Vomiting 1 1
Atrial Fibrillation 1 1
Diarrhea 1 1
Granuloma 1 1
Hypoglycemia 1 1
Test Result 1 1
Lactate Dehydrogenase Increased 1 1
Infection, Indirect 1 1
Anxiety 1 1
Complaint, Ill-Defined 1 1
Ventilator Dependent 1 1
Pain 1 1
Pleural Effusion 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
Not Applicable 1 1
Hemorrhage/Bleeding 1 1
Liver Damage/Dysfunction 1 1
Uveitis 1 1
Arthralgia 1 1
Disability 1 1
Diaphoresis 1 1
Unspecified Heart Problem 1 1
Renal Impairment 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Fall 1 1
Hypersensitivity/Allergic reaction 1 1
Inflammation 1 1
Misdiagnosis 1 1
Chills 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CardioQuip, LLC II Oct-07-2021
2 CardioQuip, LLC II Oct-06-2021
3 Cincinnati Sub-Zero Products LLC II Feb-13-2018
4 Cincinnati Sub-Zero Products LLC, a Gentherm Company II Feb-13-2019
5 Cincinnati Sub-Zero Products LLC, a Gentherm Company II Oct-03-2018
6 Gentherm Medical, LLC II Jul-19-2021
7 LivaNova USA II May-18-2018
8 LivaNova USA Inc. II Mar-13-2020
9 LivaNova USA Inc. II Oct-25-2019
10 LivaNova USA Inc. II Apr-06-2019
11 Maquet Medical Systems USA II Jul-23-2021
12 Terumo Cardiovascular Systems Corporation II Jun-04-2021
13 Terumo Cardiovascular Systems Corporation II Apr-18-2018
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