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 Code	DWC
Regulation Number	870.4250
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Microbial Contamination of Device	2183	2183
Temperature Problem	367	367
Pumping Problem	306	306
Electrical Shorting	207	207
Insufficient Cooling	173	173
Insufficient Heating	125	125
Fluid/Blood Leak	112	112
Appropriate Term/Code Not Available	108	108
Pumping Stopped	52	52
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
Infusion or Flow Problem	21	21
Electrical /Electronic Property 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
Contamination /Decontamination Problem	7	7
Incorrect, Inadequate or Imprecise Result or Readings	7	7
Power Problem	7	7
Excessive Heating	7	7
Display or Visual Feedback Problem	7	7
Mechanical Problem	7	7
Device Displays Incorrect Message	7	7
No Apparent Adverse Event	6	6
Ambient Temperature Problem	6	6
Defective Device	6	6
Break	6	6
Sparking	6	6
Circuit Failure	6	6
Failure to Power Up	6	6
Device Contamination with Chemical or Other Material	4	4
Device Sensing Problem	4	4
Labelling, Instructions for Use or Training Problem	4	4
Complete Loss of Power	4	4
Gas Output Problem	4	4
No Display/Image	4	4
Defective Component	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	2366	2366
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
Abdominal Pain	3	3
Endocarditis	3	3
Fatigue	3	3
Hypothermia	3	3
Multiple Organ Failure	3	3
Post Operative Wound Infection	3	3
Weight Changes	2	2
High Blood Pressure/ Hypertension	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Unspecified Heart Problem	2	2
No Code Available	2	2
Sepsis	2	2
Bradycardia	2	2
Abscess	2	2
Alteration In Body Temperature	2	2
Respiratory Tract Infection	2	2
Fever	2	2
Uveitis	1	1
Ventilator Dependent	1	1
Hemorrhage/Bleeding	1	1
Fainting	1	1
Lactate Dehydrogenase Increased	1	1
Renal Impairment	1	1
Dyspnea	1	1
Cardiopulmonary Arrest	1	1
Erythema	1	1
Numbness	1	1
Vomiting	1	1
Diarrhea	1	1
Chills	1	1
Ventricular Fibrillation	1	1
Weakness	1	1
Hepatitis	1	1
Atrial Fibrillation	1	1
Abdominal Distention	1	1
Malaise	1	1
Test Result	1	1
Infection, Indirect	1	1
Disability	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