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	2139	2143
Temperature Problem	393	423
Pumping Problem	271	271
Insufficient Cooling	176	176
Electrical Shorting	170	170
Insufficient Heating	88	88
Pumping Stopped	63	63
Fluid/Blood Leak	52	52
Smoking	33	33
Contamination	24	26
No Flow	22	22
Leak/Splash	19	19
Device Emits Odor	19	19
Unexpected Shutdown	17	17
Overheating of Device	17	17
Insufficient Information	17	17
Failure to Pump	15	15
Device Alarm System	14	14
Biofilm coating in Device	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
Ambient Temperature Problem	6	6
Display or Visual Feedback Problem	5	5
No Apparent Adverse Event	5	5
Infusion or Flow Problem	5	5
Therapeutic or Diagnostic Output Failure	5	6
Incorrect, Inadequate or Imprecise Result or Readings	4	4
Excessive Cooling	4	4
Melted	4	4
Excessive Heating	4	4
Labelling, Instructions for Use or Training Problem	4	4
Electrical Overstress	4	4
Contamination /Decontamination Problem	3	3
Noise, Audible	3	3
Sparking	3	3
No Display/Image	3	3
Mechanical Problem	3	4
Difficult to Open or Close	3	3
Failure of Device to Self-Test	3	3
Fail-Safe Did Not Operate	3	3
Circuit Failure	2	2
Fire	2	2
Device Contamination with Body Fluid	2	2
Corroded	2	2
Output Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3196	3227
Bacterial Infection	273	275
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