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 Code	DWC
Regulation Number	870.4250
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Microbial Contamination of Device	2124	2128
Temperature Problem	388	418
Pumping Problem	264	264
Insufficient Cooling	174	174
Electrical Shorting	170	170
Insufficient Heating	86	86
Pumping Stopped	59	59
Fluid/Blood Leak	51	51
Smoking	32	32
No Flow	22	22
Contamination	21	23
Leak/Splash	19	19
Device Emits Odor	19	19
Unexpected Shutdown	17	17
Overheating of Device	17	17
Insufficient Information	17	17
Device Alarm System	14	14
Biofilm coating in Device	13	13
Failure to Pump	13	13
Adverse Event Without Identified Device or Use Problem	11	11
Insufficient Flow or Under Infusion	10	10
Electrical /Electronic Property Problem	8	8
Complete Loss of Power	8	8
Gas Output Problem	6	6
Appropriate Term/Code Not Available	6	6
Power Problem	6	6
Therapeutic or Diagnostic Output Failure	5	6
Display or Visual Feedback Problem	5	5
No Apparent Adverse Event	5	5
Ambient Temperature Problem	5	5
Infusion or Flow Problem	5	5
Electrical Overstress	4	4
Incorrect, Inadequate or Imprecise Result or Readings	4	4
Melted	4	4
Excessive Cooling	4	4
Excessive Heating	4	4
Labelling, Instructions for Use or Training Problem	4	4
Noise, Audible	3	3
Sparking	3	3
No Display/Image	3	3
Difficult to Open or Close	3	3
Mechanical Problem	3	4
Failure of Device to Self-Test	3	3
Fail-Safe Did Not Operate	3	3
Circuit Failure	2	2
Material Integrity Problem	2	2
Corroded	2	2
Fire	2	2
Contamination /Decontamination Problem	2	2
Device Contamination with Body Fluid	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3156	3187
Bacterial Infection	270	272
Insufficient Information	44	47
No Consequences Or Impact To Patient	28	28
No Patient Involvement	27	27
No Known Impact Or Consequence To Patient	13	13
Unspecified Infection	8	12
Alteration in Body Temperature	7	7
Death	3	3
Multiple Organ Failure	3	3
Pain	3	3
High Blood Pressure/ Hypertension	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Sepsis	2	2
Respiratory Tract Infection	2	2
Hypothermia	2	2
Bradycardia	2	2
Unspecified Heart Problem	2	2
Abdominal Pain	1	1
Hearing Impairment	1	1
Impaired Healing	1	1
Weight Changes	1	1
Liver Damage/Dysfunction	1	1
Pneumothorax	1	1
Unspecified Gastrointestinal Problem	1	1
Abdominal Distention	1	1
Fever	1	1
Erythema	1	1
Renal Impairment	1	1
Lactate Dehydrogenase Increased	1	1
Hemorrhage/Bleeding	1	1
Ventilator Dependent	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	Gentherm Medical, LLC	II	Jul-19-2021
6	LivaNova Deutschland GmbH	II	Oct-06-2023
7	Maquet Medical Systems USA	II	Jul-23-2021
8	Terumo Cardiovascular Systems Corporation	II	Jun-04-2021