TPLC - Total Product Life Cycle

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Device	microfilter, blood transfusion
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	591	591
Coagulation in Device or Device Ingredient	302	302
Filtration Problem	129	129
Restricted Flow rate	101	101
Defective Component	77	77
High Readings	59	59
High Test Results	56	56
Contamination of Device Ingredient or Reagent	43	43
Insufficient Information	43	43
Therapeutic or Diagnostic Output Failure	21	21
Product Quality Problem	8	8
Incorrect, Inadequate or Imprecise Result or Readings	8	8
Inadequate Filtration Process	6	6
No Apparent Adverse Event	5	5
Device Ingredient or Reagent Problem	4	4
Misassembly by Users	3	3
Obstruction of Flow	3	3
Defective Device	3	3
Use of Device Problem	3	3
Misassembled	3	3
Contamination /Decontamination Problem	2	2
Break	2	2
Device Contamination with Body Fluid	2	2
Improper Chemical Reaction	2	2
Appropriate Term/Code Not Available	2	2
Pressure Problem	1	1
Fungus in Device Environment	1	1
Device Difficult to Setup or Prepare	1	1
Fluid/Blood Leak	1	1
Device Damaged Prior to Use	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Patient Involvement	494	494
No Known Impact Or Consequence To Patient	277	277
No Clinical Signs, Symptoms or Conditions	210	210
No Consequences Or Impact To Patient	70	70
Hemolysis	5	5
Insufficient Information	2	2
Alteration in Body Temperature	1	1
Pain	1	1
Perforation of Esophagus	1	1