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	2192	2196
Temperature Problem	393	422
Pumping Problem	280	280
Insufficient Cooling	179	179
Electrical Shorting	171	171
Insufficient Heating	84	84
Pumping Stopped	69	69
Fluid/Blood Leak	52	52
Smoking	30	30
No Flow	21	21
Unexpected Shutdown	18	18
Failure to Pump	18	18
Leak/Splash	18	18
Contamination	17	17
Device Emits Odor	17	17
Overheating of Device	16	16
Insufficient Device Problem Information	16	16
Device Alarm System	13	13
Biofilm coating in Device	12	12
Insufficient Flow or Under Infusion	12	12
Electrical /Electronic Property Problem	8	8
Complete Loss of Power	8	8
Ambient Temperature Problem	6	6
Gas Output Problem	6	6
Power Problem	6	6
Appropriate Device Problem Term/Code Not Available	6	6
Infusion or Flow Problem	5	5
No Apparent Adverse Event	5	5
Excessive Heating	4	4
Excessive Cooling	4	4
Labelling, Instructions for Use or Training Problem	4	4
Incorrect, Inadequate or Imprecise Result or Readings	4	4
Electrical Overstress	4	4
Contamination /Decontamination Problem	3	3
Display or Visual Feedback Problem	3	3
Fail-Safe Did Not Operate	3	3
Noise, Audible	3	3
Therapeutic or Diagnostic Output Failure	3	3
Difficult to Open or Close	3	3
No Display/Image	3	3
Melted	3	3
Failure of Device to Self-Test	2	2
Sparking	2	2
Calibration Problem	2	2
Circuit Failure	2	2
Mechanical Problem	2	2
Device Contamination with Body Fluid	2	2
Incorrect Measurement	2	2
False Alarm	2	2
Key or Button Unresponsive/not Working	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3299	3330
Bacterial Infection	273	275
Insufficient Information	45	48
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
Pain	3	3
Death	3	3
Multiple Organ Dysfunction Syndrome	3	3
Unspecified Heart Problem	2	2
Sepsis	2	2
Hypothermia	2	2
Bradycardia	2	2
Respiratory Tract Infection	2	2
Intraoperative Cardiac Valve Injury	2	2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	2	2
High Blood Pressure/ Hypertension	2	2
Lactate Dehydrogenase Increased	1	1
Hemorrhage/Blood Loss/Bleeding	1	1
Renal Impairment	1	1
Pneumothorax	1	1
Hearing Impairment	1	1
Liver Damage/Dysfunction	1	1
Bacteremia	1	1
Abdominal Distention	1	1
Ventilator Dependent	1	1
Weight Changes	1	1
Abdominal Pain	1	1
Erythema	1	1
Impaired Healing	1	1
Unspecified Gastrointestinal Problem	1	1
Fever	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