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	2150	2150
Temperature Problem	426	456
Pumping Problem	338	338
Electrical Shorting	182	182
Insufficient Cooling	181	181
Insufficient Heating	113	113
Fluid/Blood Leak	62	62
Pumping Stopped	60	60
Smoking	39	39
No Flow	24	24
Unexpected Shutdown	22	22
Insufficient Information	22	22
Contamination	21	23
Device Emits Odor	20	20
Leak/Splash	19	19
Overheating of Device	18	18
Failure to Pump	18	18
Adverse Event Without Identified Device or Use Problem	17	17
Device Alarm System	14	14
Biofilm coating in Device	13	13
Infusion or Flow Problem	13	13
Electrical /Electronic Property Problem	10	10
Therapeutic or Diagnostic Output Failure	10	11
Gas Output Problem	7	7
Complete Loss of Power	7	7
Device Displays Incorrect Message	6	6
Melted	6	6
Power Problem	6	6
No Apparent Adverse Event	6	6
Ambient Temperature Problem	6	6
Incorrect, Inadequate or Imprecise Result or Readings	6	6
Contamination /Decontamination Problem	6	6
Display or Visual Feedback Problem	5	5
Output Problem	5	5
Excessive Heating	5	5
Noise, Audible	4	4
Appropriate Term/Code Not Available	4	4
Device Sensing Problem	4	4
Labelling, Instructions for Use or Training Problem	4	4
Excessive Cooling	4	4
Defective Device	4	4
Circuit Failure	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
Device Contamination with Chemical or Other Material	3	7
Fail-Safe Did Not Operate	3	3
Electrical Overstress	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2854	2883
Bacterial Infection	348	348
No Patient Involvement	197	197
No Known Impact Or Consequence To Patient	188	188
No Consequences Or Impact To Patient	125	125
Insufficient Information	45	48
Death	17	17
Unspecified Infection	12	16
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