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	2226	2226
Temperature Problem	349	349
Pumping Problem	291	291
Electrical Shorting	213	213
Appropriate Term/Code Not Available	185	185
Insufficient Cooling	172	172
Insufficient Heating	142	142
Fluid/Blood Leak	124	124
Device Displays Incorrect Message	99	99
Adverse Event Without Identified Device or Use Problem	52	52
Electrical /Electronic Property Problem	51	51
Pumping Stopped	49	49
Smoking	46	46
No Flow	28	28
Insufficient Information	26	26
Unexpected Shutdown	25	25
Failure to Pump	25	25
Infusion or Flow Problem	25	25
Device Emits Odor	24	24
Leak/Splash	23	23
Contamination	23	23
Overheating of Device	21	21
Noise, Audible	18	18
Device Alarm System	15	15
Biofilm coating in Device	13	13
Melted	13	13
Thermal Decomposition of Device	12	12
Device Operates Differently Than Expected	11	11
Mechanical Problem	11	11
Display or Visual Feedback Problem	10	10
Output Problem	10	10
Defective Component	9	9
Therapeutic or Diagnostic Output Failure	9	9
Power Problem	8	8
Excessive Cooling	8	8
No Display/Image	8	8
Loss of Power	8	8
Failure to Power Up	8	8
Device Issue	8	8
Excessive Heating	7	7
Contamination /Decontamination Problem	7	7
Defective Device	7	7
Break	7	7
Incorrect, Inadequate or Imprecise Result or Readings	7	7
Circuit Failure	6	6
Use of Device Problem	6	6
Sparking	6	6
No Apparent Adverse Event	6	6
Ambient Temperature Problem	6	6
Device Contamination with Chemical or Other Material	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2156	2156
No Patient Involvement	705	705
No Known Impact Or Consequence To Patient	591	591
Bacterial Infection	401	401
No Consequences Or Impact To Patient	348	348
Death	47	47
Insufficient Information	42	42
Unspecified Infection	23	23
No Information	11	11
Alteration in Body Temperature	9	9
Fever	9	9
Fatigue	9	9
Endocarditis	8	8
Weight Changes	6	6
Abscess	4	4
Sepsis	4	4
Abdominal Pain	3	3
Multiple Organ Failure	3	3
Post Operative Wound Infection	3	3
Weakness	3	3
Hypothermia	3	3
No Code Available	2	2
High Blood Pressure/ Hypertension	2	2
Unspecified Heart Problem	2	2
Malaise	2	2
Pneumonia	2	2
Bradycardia	2	2
Alteration In Body Temperature	2	2
Dyspnea	2	2
Erythema	2	2
Respiratory Tract Infection	2	2
Uveitis	1	1
Ventilator Dependent	1	1
Thrombus	1	1
Granuloma	1	1
Hemorrhage/Bleeding	1	1
Fainting	1	1
Non specific EKG/ECG Changes	1	1
Anxiety	1	1
Hypoglycemia	1	1
Hearing Impairment	1	1
Lactate Dehydrogenase Increased	1	1
Renal Impairment	1	1
Pain	1	1
Fall	1	1
Cardiopulmonary Arrest	1	1
Numbness	1	1
Vomiting	1	1
Pleural Effusion	1	1
Diarrhea	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	II	Feb-13-2018
6	Cincinnati Sub-Zero Products LLC, a Gentherm Company	II	Feb-13-2019
7	Cincinnati Sub-Zero Products LLC, a Gentherm Company	II	Oct-03-2018
8	Gentherm Medical, LLC	II	Jul-19-2021
9	LivaNova Deutschland GmbH	II	Oct-06-2023
10	LivaNova USA	II	May-18-2018
11	LivaNova USA Inc.	II	Mar-13-2020
12	LivaNova USA Inc.	II	Oct-25-2019
13	LivaNova USA Inc.	II	Apr-06-2019
14	Maquet Medical Systems USA	II	Jul-23-2021
15	Terumo Cardiovascular Systems Corporation	II	Jun-04-2021
16	Terumo Cardiovascular Systems Corporation	II	Apr-18-2018