TPLC - Total Product Life Cycle

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Device	container, empty, for collection & processing of blood & blood components
Product Code	KSR
Regulation Number	864.9100
Device Class	2

Premarket Reviews
Manufacturer	Decision
FENWAL INC
	SUBSTANTIALLY EQUIVALENT	1
FRESENIUS KABI AG
	SUBSTANTIALLY EQUIVALENT	4
HAEMONETICS MANUFACTURING INC.
	SUBSTANTIALLY EQUIVALENT	2
ORIGEN BIOMEDICAL
	SUBSTANTIALLY EQUIVALENT	2
PURIBLOOD MEDICAL CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
TERUMO BCT, INC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fracture	34	34
Appropriate Term/Code Not Available	18	18
Crack	17	17
Adverse Event Without Identified Device or Use Problem	9	9
Insufficient Information	8	8
Fluid/Blood Leak	8	8
Leak/Splash	8	8
Detachment of Device or Device Component	7	7
Break	6	6
Burst Container or Vessel	6	6
Material Puncture/Hole	5	5
Material Integrity Problem	4	4
Loose or Intermittent Connection	3	3
Device Disinfection Or Sterilization Issue	2	2
Defective Component	2	2
Improper or Incorrect Procedure or Method	2	2
Device Operates Differently Than Expected	2	2
Component Missing	2	2
Particulates	2	2
Use of Device Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
No Apparent Adverse Event	1	1
Material Frayed	1	1
Human-Device Interface Problem	1	1
Tear, Rip or Hole in Device Packaging	1	1
Product Quality Problem	1	1
Failure To Adhere Or Bond	1	1
Restricted Flow rate	1	1
Free or Unrestricted Flow	1	1
Material Rupture	1	1
Scratched Material	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Device Markings/Labelling Problem	1	1
Filtration Problem	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Contamination of Device Ingredient or Reagent	1	1
Material Deformation	1	1
Protective Measures Problem	1	1
Hole In Material	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	43	43
No Known Impact Or Consequence To Patient	40	40
Insufficient Information	10	10
No Information	8	8
No Patient Involvement	5	5
Unspecified Infection	2	2
Needle Stick/Puncture	2	2
Pain	1	1
Toxicity	1	1
Osteopenia/ Osteoporosis	1	1
Hemorrhage/Bleeding	1	1
Thromboembolism	1	1
Renal Failure	1	1
Low Blood Pressure/ Hypotension	1	1
Respiratory Failure	1	1
Infection, Indirect	1	1
Disseminated Intravascular Coagulation (DIC)	1	1
Tachycardia	1	1
Muscle/Tendon Damage	1	1
No Consequences Or Impact To Patient	1	1
Bone Fracture(s)	1	1
Death	1	1
Abdominal Pain	1	1
No Code Available	1	1
Chemical Exposure	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	DeRoyal Industries Inc	II	Apr-12-2012