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
SISU GLOBAL HEALTH
	SUBSTANTIALLY EQUIVALENT	1
SORIN GROUP ITALIA S.R.L.
	SUBSTANTIALLY EQUIVALENT	2
1. K240584 XTRA Autotransfusion System (with XTRA Bowl sets)
2. K241236 XTRA Collection sets; XTRA Sequestration set X

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	190	190
Mechanical Problem	85	85
Material Deformation	43	43
Crack	39	39
Optical Problem	35	35
Material Integrity Problem	31	31
Obstruction of Flow	27	27
Noise, Audible	23	23
Device Alarm System	23	23
Electrical /Electronic Property Problem	21	21
Device Misassembled During Manufacturing /Shipping	15	15
Nonstandard Device	15	15
Material Puncture/Hole	13	13
Insufficient Device Problem Information	12	12
Air/Gas in Device	11	11
Adverse Event Without Identified Device or Use Problem	9	9
Delivered as Unsterile Product	8	8
Break	7	7
No Apparent Adverse Event	5	6
Material Separation	4	4
Smoking	4	4
Use of Device Problem	3	3
Detachment of Device or Device Component	3	11
Appropriate Device Problem Term/Code Not Available	3	3
Contamination	2	2
Material Twisted/Bent	2	2
Leak/Splash	2	2
Connection Problem	2	2
Fracture	2	2
Suction Problem	2	2
Disconnection	2	2
Infusion or Flow Problem	2	2
Burst Container or Vessel	2	2
Application Program Freezes or Fails to Launch	1	1
Temperature Problem	1	1
Gas/Air Leak	1	1
Incorrect Measurement	1	1
Off-Label Use	1	1
Overheating of Device	1	1
Sharp Edges	1	1
Free or Unrestricted Flow	1	1
Power Problem	1	1
Increase in Suction	1	1
Blocked Connection	1	1
Chemical Problem	1	1
Unclear Information	1	1
Misassembled During Installation	1	1
Unsealed Device Packaging	1	1
Decrease in Suction	1	1
Manufacturing, Packaging or Shipping Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	361	372
Hemorrhage/Blood Loss/Bleeding	146	146
Insufficient Information	16	18
Unspecified Blood or Lymphatic problem	12	12
Hypovolemia	5	5
Hemolysis	5	5
Perforation of Vessels	3	3
Low Cardiac Output	3	3
Low Blood Pressure/ Hypotension	3	3
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	3	3
Unspecified Tissue Injury	2	2
Pneumothorax	2	2
Thrombosis/Thrombus	2	2
Renal Failure	2	2
Bradycardia	2	2
Cognitive Changes	1	1
Ruptured Aneurysm	1	1
No Information	1	1
Pulmonary Embolism	1	1
Blister	1	1
Anemia	1	1
Low Oxygen Saturation	1	1
Inflammation	1	1
Aspiration Pneumonitis	1	1
Post Operative Wound Infection	1	1
Local Reaction	1	1
No Consequences Or Impact To Patient	1	1
Cardiac Arrest	1	1
Myocardial Contusion	1	1
Dyspnea	1	1
Cough	1	1
Unspecified Heart Problem	1	1
Kidney injury	1	1
Skin Tears	1	1