TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ATRIUM MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
FRESENIUS KABI AG
	SUBSTANTIALLY EQUIVALENT	1
HAEMONETICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
INARI MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
INARI MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
INQUIS MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
1. K240426 Aventus Clot Management System
PROCELL SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
SISU GLOBAL HEALTH
	SUBSTANTIALLY EQUIVALENT	1
SORIN GROUP ITALIA S.R.L.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	185	185
Crack	90	90
Mechanical Problem	70	70
Material Deformation	35	35
Material Integrity Problem	29	29
Optical Problem	25	25
Obstruction of Flow	24	24
Noise, Audible	18	18
Electrical /Electronic Property Problem	18	18
Device Alarm System	18	18
Insufficient Information	17	17
Adverse Event Without Identified Device or Use Problem	17	17
Nonstandard Device	15	15
Device Misassembled During Manufacturing /Shipping	15	15
Material Puncture/Hole	12	12
Leak/Splash	10	12
Air/Gas in Device	8	8
Break	7	7
Suction Problem	6	6
Gas/Air Leak	6	7
Appropriate Term/Code Not Available	5	5
Improper or Incorrect Procedure or Method	4	4
Smoking	4	4
Material Twisted/Bent	4	4
Connection Problem	3	3
No Apparent Adverse Event	3	3
Detachment of Device or Device Component	3	11
Delivered as Unsterile Product	3	3
Infusion or Flow Problem	3	3
Contamination /Decontamination Problem	3	3
Disconnection	3	3
Defective Device	3	3
Therapeutic or Diagnostic Output Failure	3	3
Loose or Intermittent Connection	2	2
Burst Container or Vessel	2	2
Fracture	2	2
Material Separation	2	2
Contamination	2	2
Use of Device Problem	2	2
Manufacturing, Packaging or Shipping Problem	1	1
Decrease in Suction	1	1
Blocked Connection	1	1
Defective Component	1	1
Sharp Edges	1	1
Misconnection	1	1
Unsealed Device Packaging	1	1
Calibration Problem	1	1
Unclear Information	1	1
Device Markings/Labelling Problem	1	1
Incorrect Measurement	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	328	338
Hemorrhage/Bleeding	116	116
No Known Impact Or Consequence To Patient	41	41
Insufficient Information	17	18
No Consequences Or Impact To Patient	14	14
Unspecified Blood or Lymphatic problem	12	12
No Patient Involvement	11	11
No Information	6	6
Blood Loss	6	6
Hypovolemia	5	5
Death	5	5
Hemolysis	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Pneumothorax	3	3
Low Blood Pressure/ Hypotension	3	3
Low Cardiac Output	3	3
Respiratory Distress	2	2
Thrombosis/Thrombus	2	2
Pleural Effusion	2	2
Bradycardia	2	2
Renal Failure	2	2
Unspecified Tissue Injury	2	2
Aspiration Pneumonitis	1	1
Pulmonary Embolism	1	1
Low Oxygen Saturation	1	1
Hemothorax	1	1
Unspecified Heart Problem	1	1
Ruptured Aneurysm	1	1
Skin Tears	1	1
Cough	1	1
Sudden Cardiac Death	1	1
Myocardial Contusion	1	1
Post Operative Wound Infection	1	1
Cardiac Arrest	1	1
Blister	1	1
Cognitive Changes	1	1
Local Reaction	1	1
Anemia	1	1
Inflammation	1	1
Unspecified Infection	1	1
Air Embolism	1	1