TPLC - Total Product Life Cycle

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Device	controller, temperature, cardiopulmonary bypass
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	2043	2043
Temperature Problem	346	346
Pumping Problem	287	287
Electrical Shorting	198	198
Insufficient Cooling	161	161
Insufficient Heating	123	123
Fluid/Blood Leak	112	112
Appropriate Term/Code Not Available	108	108
Pumping Stopped	47	47
Smoking	44	44
No Flow	26	26
Unexpected Shutdown	24	24
Insufficient Information	24	24
Adverse Event Without Identified Device or Use Problem	24	24
Leak/Splash	22	22
Contamination	22	22
Electrical /Electronic Property Problem	21	21
Device Emits Odor	21	21
Infusion or Flow Problem	20	20
Failure to Pump	19	19
Overheating of Device	17	17
Device Alarm System	14	14
Biofilm coating in Device	13	13
Noise, Audible	12	12
Melted	10	10
Output Problem	9	9
Therapeutic or Diagnostic Output Failure	9	9
Excessive Cooling	8	8
Mechanical Problem	7	7
Device Displays Incorrect Message	7	7
Excessive Heating	7	7
Power Problem	7	7
Contamination /Decontamination Problem	7	7
Incorrect, Inadequate or Imprecise Result or Readings	7	7
Display or Visual Feedback Problem	6	6
Ambient Temperature Problem	6	6
No Apparent Adverse Event	6	6
Failure to Power Up	6	6
Circuit Failure	6	6
Sparking	6	6
Defective Device	6	6
Break	6	6
Defective Component	4	4
Gas Output Problem	4	4
No Display/Image	4	4
Complete Loss of Power	4	4
Labelling, Instructions for Use or Training Problem	4	4
Device Sensing Problem	4	4
Device Contamination with Chemical or Other Material	4	4
Difficult to Open or Close	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2156	2156
No Patient Involvement	471	471
No Known Impact Or Consequence To Patient	424	424
Bacterial Infection	358	358
No Consequences Or Impact To Patient	257	257
Insufficient Information	42	42
Death	32	32
Unspecified Infection	15	15
Alteration in Body Temperature	9	9
No Information	4	4
Endocarditis	3	3
Hypothermia	3	3
Post Operative Wound Infection	3	3
Multiple Organ Failure	3	3
Fatigue	3	3
Abdominal Pain	3	3
Sepsis	2	2
No Code Available	2	2
High Blood Pressure/ Hypertension	2	2
Unspecified Heart Problem	2	2
Weight Changes	2	2
Bradycardia	2	2
Abscess	2	2
Alteration In Body Temperature	2	2
Fever	2	2
Respiratory Tract Infection	2	2
Uveitis	1	1
Ventilator Dependent	1	1
Hemorrhage/Bleeding	1	1
Fainting	1	1
Lactate Dehydrogenase Increased	1	1
Renal Impairment	1	1
Pain	1	1
Dyspnea	1	1
Cardiopulmonary Arrest	1	1
Non specific EKG/ECG Changes	1	1
Numbness	1	1
Vomiting	1	1
Erythema	1	1
Diarrhea	1	1
Hearing Impairment	1	1
Impaired Healing	1	1
Patient Problem/Medical Problem	1	1
Chills	1	1
Weakness	1	1
Ventricular Fibrillation	1	1
Hepatitis	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Liver Damage/Dysfunction	1	1
Atrial Fibrillation	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	Cincinnati Sub-Zero Products LLC, a Gentherm Company	II	Feb-13-2019
6	Gentherm Medical, LLC	II	Jul-19-2021
7	LivaNova Deutschland GmbH	II	Oct-06-2023
8	LivaNova USA Inc.	II	Mar-13-2020
9	LivaNova USA Inc.	II	Oct-25-2019
10	LivaNova USA Inc.	II	Apr-06-2019
11	Maquet Medical Systems USA	II	Jul-23-2021
12	Terumo Cardiovascular Systems Corporation	II	Jun-04-2021