TPLC - Total Product Life Cycle

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Device	microfilter, blood transfusion
Regulation Description	Intravascular administration set.
Product Code	CAK
Regulation Number	880.5440
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	355	355
Coagulation in Device or Device Ingredient	73	73
Filtration Problem	70	70
Insufficient Information	65	65
Restricted Flow rate	45	45
Contamination of Device Ingredient or Reagent	41	41
High Readings	39	39
High Test Results	38	38
Defective Component	17	17
Therapeutic or Diagnostic Output Failure	13	13
Inadequate Filtration Process	9	9
No Apparent Adverse Event	5	5
Device Ingredient or Reagent Problem	4	4
Obstruction of Flow	4	4
Use of Device Problem	3	3
Misassembled	3	3
Misassembly by Users	3	3
Improper Chemical Reaction	2	2
Pressure Problem	1	1
Device Damaged Prior to Use	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Contamination /Decontamination Problem	1	1
Device Difficult to Setup or Prepare	1	1
Partial Blockage	1	1
Product Quality Problem	1	1
Fungus in Device Environment	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	252	252
No Patient Involvement	160	160
No Consequences Or Impact To Patient	61	61
No Known Impact Or Consequence To Patient	25	25
Hemolysis	5	5
Insufficient Information	2	2
Perforation of Esophagus	1	1
Alteration in Body Temperature	1	1
Pain	1	1