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	597	597
Coagulation in Device or Device Ingredient	302	302
Filtration Problem	136	136
Defective Component	129	129
Restricted Flow rate	105	105
High Test Results	70	70
High Readings	61	61
Contamination of Device Ingredient or Reagent	43	43
Insufficient Information	43	43
Therapeutic or Diagnostic Output Failure	21	21
Incorrect, Inadequate or Imprecise Result or Readings	10	10
Inadequate Filtration Process	8	8
Product Quality Problem	8	8
Device Operates Differently Than Expected	7	7
Device Ingredient or Reagent Problem	5	5
No Apparent Adverse Event	5	5
Misassembly by Users	3	3
Obstruction of Flow	3	3
Misassembled	3	3
Use of Device Problem	3	3
Defective Device	3	3
Contamination /Decontamination Problem	2	2
Break	2	2
Device Contamination with Body Fluid	2	2
Human-Device Interface Problem	2	2
Improper Chemical Reaction	2	2
Appropriate Term/Code Not Available	2	2
Pressure Problem	1	1
Incorrect Or Inadequate Test Results	1	1
Device Difficult to Setup or Prepare	1	1
Fluid/Blood Leak	1	1
Material Discolored	1	1
Device Damaged Prior to Use	1	1
Fungus in Device Environment	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Patient Involvement	551	551
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
Reaction	1	1