TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
BRIDGE TO LIFE LTD.
	SUBSTANTIALLY EQUIVALENT	2
INSTITUT GEORGES LOPEZ
	SUBSTANTIALLY EQUIVALENT	1
PARAGONIX TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	3
PARAGONIX TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
	SUBSTANTIALLY EQUIVALENT - KIT	1
PRAGONIX TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT - KIT	1
PRESERVATION SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	3
S.A.L.F. SPA
	SUBSTANTIALLY EQUIVALENT	3
UNITED THERAPEUTICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
WATERS MEDICAL SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	1
XVIVO PERFUSION AB
	SUBSTANTIALLY EQUIVALENT	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	12	12
Device Contamination With Biological Material	3	3
Microbial Contamination of Device	3	3
Device Emits Odor	3	3
Adverse Event Without Identified Device or Use Problem	2	2
Insufficient Information	1	1
No Audible Alarm	1	1
Pumping Stopped	1	1
Contamination	1	1
Device Displays Incorrect Message	1	1
Device Markings/Labelling Problem	1	1
Product Quality Problem	1	1
Contamination of Device Ingredient or Reagent	1	1
Nonstandard Device	1	1
Hole In Material	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	8	8
No Patient Involvement	6	6
No Consequences Or Impact To Patient	4	4
Unspecified Infection	1	1
Death	1	1
Complaint, Ill-Defined	1	1
Sepsis	1	1
Fungal Infection	1	1
No Code Available	1	1
No Information	1	1
Fever	1	1
Insufficient Information	1	1
Abscess	1	1
Bacterial Infection	1	1
Low Blood Pressure/ Hypotension	1	1
Urinary Tract Infection	1	1