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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
Regulation Description Cardiopulmonary bypass temperature controller.
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
  1.  K191402  Heater-Cooler System 3T
  2.  K220635  Heater-Cooler System 3T
SPECTRUM MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 697 697
2020 548 548
2021 622 622
2022 605 605
2023 928 928
2024 558 558
2025 41 70

Device Problems MDRs with this Device Problem Events in those MDRs
Microbial Contamination of Device 2211 2211
Temperature Problem 369 398
Pumping Problem 308 308
Electrical Shorting 209 209
Insufficient Cooling 177 177
Insufficient Heating 125 125
Fluid/Blood Leak 112 112
Appropriate Term/Code Not Available 108 108
Pumping Stopped 55 55
Smoking 45 45
Unexpected Shutdown 26 26
No Flow 26 26
Adverse Event Without Identified Device or Use Problem 24 24
Insufficient Information 24 24
Leak/Splash 22 22
Contamination 22 22
Electrical /Electronic Property Problem 21 21
Infusion or Flow Problem 21 21
Device Emits Odor 21 21
Failure to Pump 19 19
Overheating of Device 18 18
Device Alarm System 15 15
Biofilm coating in Device 13 13
Noise, Audible 12 12
Therapeutic or Diagnostic Output Failure 11 11
Melted 10 10
Output Problem 9 9
Excessive Cooling 8 8
Device Displays Incorrect Message 7 7
Power Problem 7 7
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Excessive Heating 7 7
Contamination /Decontamination Problem 7 7
Mechanical Problem 7 7
Display or Visual Feedback Problem 7 7
Sparking 6 6
Circuit Failure 6 6
Ambient Temperature Problem 6 6
Defective Device 6 6
Failure to Power Up 6 6
No Apparent Adverse Event 6 6
Break 6 6
Defective Component 4 4
Complete Loss of Power 4 4
Device Contamination with Chemical or Other Material 4 4
Gas Output Problem 4 4
Device Sensing Problem 4 4
Labelling, Instructions for Use or Training Problem 4 4
No Display/Image 4 4
Intermittent Loss of Power 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2405 2434
No Patient Involvement 471 471
No Known Impact Or Consequence To Patient 424 424
Bacterial Infection 368 368
No Consequences Or Impact To Patient 257 257
Insufficient Information 43 43
Death 32 32
Unspecified Infection 15 15
Alteration in Body Temperature 9 9
No Information 4 4
Pain 4 4
Multiple Organ Failure 3 3
Hypothermia 3 3
Abdominal Pain 3 3
Post Operative Wound Infection 3 3
Endocarditis 3 3
Fatigue 3 3
Bradycardia 2 2
Alteration In Body Temperature 2 2
Unspecified Heart Problem 2 2
High Blood Pressure/ Hypertension 2 2
No Code Available 2 2
Sepsis 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Fever 2 2
Weight Changes 2 2
Abscess 2 2
Respiratory Tract Infection 2 2
Atrial Fibrillation 1 1
Renal Impairment 1 1
Fainting 1 1
Hemorrhage/Bleeding 1 1
Ventricular Fibrillation 1 1
Malaise 1 1
Cardiopulmonary Arrest 1 1
Liver Damage/Dysfunction 1 1
Vomiting 1 1
Dyspnea 1 1
Hearing Impairment 1 1
Arthralgia 1 1
Infection, Indirect 1 1
Chills 1 1
Unspecified Gastrointestinal Problem 1 1
Uveitis 1 1
Weakness 1 1
Disability 1 1
Non specific EKG/ECG Changes 1 1
Patient Problem/Medical Problem 1 1
Lactate Dehydrogenase Increased 1 1
Hepatitis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CardioQuip, LLC II Dec-15-2023
2 CardioQuip, LLC II Dec-01-2023
3 CardioQuip, LLC II Oct-07-2021
4 CardioQuip, LLC II Oct-06-2021
5 Cincinnati Sub-Zero Products LLC, a Gentherm Company II Feb-13-2019
6 Gentherm Medical, LLC II Jul-19-2021
7 LivaNova Deutschland GmbH II Oct-06-2023
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
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