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	1941	1941
Temperature Problem	344	373
Pumping Problem	302	302
Electrical Shorting	152	152
Insufficient Cooling	148	148
Insufficient Heating	104	104
Fluid/Blood Leak	60	60
Pumping Stopped	47	47
Smoking	39	39
No Flow	24	24
Insufficient Information	22	22
Contamination	21	21
Device Emits Odor	20	20
Leak/Splash	19	19
Unexpected Shutdown	18	18
Adverse Event Without Identified Device or Use Problem	17	17
Overheating of Device	17	17
Failure to Pump	16	16
Device Alarm System	14	14
Biofilm coating in Device	13	13
Infusion or Flow Problem	12	12
Therapeutic or Diagnostic Output Failure	10	10
Electrical /Electronic Property Problem	8	8
Ambient Temperature Problem	6	6
Device Displays Incorrect Message	6	6
Contamination /Decontamination Problem	6	6
Incorrect, Inadequate or Imprecise Result or Readings	6	6
Melted	6	6
No Apparent Adverse Event	5	5
Power Problem	5	5
Excessive Heating	5	5
Complete Loss of Power	5	5
Display or Visual Feedback Problem	5	5
Output Problem	5	5
Defective Device	4	4
Appropriate Term/Code Not Available	4	4
Gas Output Problem	4	4
Excessive Cooling	4	4
Device Sensing Problem	4	4
Noise, Audible	4	4
Labelling, Instructions for Use or Training Problem	4	4
Failure of Device to Self-Test	3	3
Fail-Safe Did Not Operate	3	3
Difficult to Open or Close	3	3
Device Contamination with Chemical or Other Material	3	3
Mechanical Problem	3	3
No Display/Image	3	3
Sparking	3	3
Circuit Failure	3	3
Self-Activation or Keying	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2434	2463
Bacterial Infection	334	334
No Patient Involvement	197	197
No Known Impact Or Consequence To Patient	188	188
No Consequences Or Impact To Patient	125	125
Insufficient Information	43	43
Death	17	17
Unspecified Infection	12	12
Alteration in Body Temperature	9	9
Pain	4	4
Hypothermia	3	3
Post Operative Wound Infection	3	3
Multiple Organ Failure	3	3
Unspecified Heart Problem	2	2
Bradycardia	2	2
Abscess	2	2
Respiratory Tract Infection	2	2
Fever	2	2
Alteration In Body Temperature	2	2
No Information	2	2
Sepsis	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
High Blood Pressure/ Hypertension	2	2
Abdominal Distention	1	1
Atrial Fibrillation	1	1
Malaise	1	1
Unspecified Gastrointestinal Problem	1	1
Fatigue	1	1
Chills	1	1
Pneumothorax	1	1
Liver Damage/Dysfunction	1	1
Patient Problem/Medical Problem	1	1
Erythema	1	1
Numbness	1	1
Weight Changes	1	1
Impaired Healing	1	1
Renal Impairment	1	1
Lactate Dehydrogenase Increased	1	1
Hearing Impairment	1	1
Non specific EKG/ECG Changes	1	1
Abdominal Pain	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	LivaNova USA Inc.	II	Mar-13-2020
8	Maquet Medical Systems USA	II	Jul-23-2021
9	Terumo Cardiovascular Systems Corporation	II	Jun-04-2021