TPLC - Total Product Life Cycle

show TPLC since

Premarket Reviews
Manufacturer	Decision
ATRIUM MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
1. K201305 Auto transfusion (ATS) Chest Drains: Ocean Water S ...
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
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	163	163
Crack	88	88
Mechanical Problem	52	52
Material Integrity Problem	29	29
Optical Problem	22	22
Material Deformation	21	21
Obstruction of Flow	21	21
Electrical /Electronic Property Problem	17	17
Insufficient Information	17	17
Adverse Event Without Identified Device or Use Problem	17	17
Noise, Audible	16	16
Nonstandard Device	15	15
Device Alarm System	15	15
Device Misassembled During Manufacturing /Shipping	15	15
Leak/Splash	10	10
Material Puncture/Hole	9	9
Break	6	6
Gas/Air Leak	6	6
Air/Gas in Device	6	6
Suction Problem	5	5
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
Material Discolored	3	3
Disconnection	3	3
Contamination /Decontamination Problem	3	3
Therapeutic or Diagnostic Output Failure	3	3
Defective Device	3	3
Use of Device Problem	2	2
Contamination	2	2
Loose or Intermittent Connection	2	2
Burst Container or Vessel	2	2
Fracture	2	2
Material Separation	2	2
Temperature Problem	1	1
Increase in Suction	1	1
Device Displays Incorrect Message	1	1
Chemical Problem	1	1
Pressure Problem	1	1
Overheating of Device	1	1
Material Split, Cut or Torn	1	1
Off-Label Use	1	1
Coagulation in Device or Device Ingredient	1	1
Application Program Freezes, Becomes Nonfunctional	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	289	297
Hemorrhage/Bleeding	99	99
No Known Impact Or Consequence To Patient	41	41
Insufficient Information	17	17
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
Death	5	5
Hypovolemia	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Pneumothorax	3	3
Hemolysis	3	3
Low Cardiac Output	3	3
Low Blood Pressure/ Hypotension	3	3
Respiratory Distress	2	2
Thrombosis/Thrombus	2	2
Pleural Effusion	2	2
Bradycardia	2	2
Renal Failure	2	2
Unspecified Infection	1	1
Air Embolism	1	1
Inflammation	1	1
Local Reaction	1	1
Blister	1	1
Cognitive Changes	1	1
Anemia	1	1
Cardiac Arrest	1	1
Post Operative Wound Infection	1	1
Myocardial Contusion	1	1
Sudden Cardiac Death	1	1
Cough	1	1
Skin Tears	1	1
Ruptured Aneurysm	1	1
Unspecified Heart Problem	1	1
Hemothorax	1	1
Low Oxygen Saturation	1	1
Pulmonary Embolism	1	1
Aspiration Pneumonitis	1	1