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	20	20
Crack	18	18
Adverse Event Without Identified Device or Use Problem	10	10
Leak/Splash	8	8
Detachment of Device or Device Component	8	8
Fluid/Blood Leak	8	8
Insufficient Information	8	8
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
Defective Component	2	2
Device Disinfection Or Sterilization Issue	2	2
Component Missing	2	2
Particulates	2	2
Device Operates Differently Than Expected	2	2
Improper or Incorrect Procedure or Method	2	2
Material Frayed	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Product Quality Problem	1	1
Contamination of Device Ingredient or Reagent	1	1
Tear, Rip or Hole in Device Packaging	1	1
No Apparent Adverse Event	1	1
Free or Unrestricted Flow	1	1
Material Rupture	1	1
Material Deformation	1	1
Hole In Material	1	1
Device Markings/Labelling Problem	1	1
Restricted Flow rate	1	1
Filtration Problem	1	1
Scratched Material	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Failure To Adhere Or Bond	1	1
Use of Device Problem	1	1
Protective Measures Problem	1	1
Human-Device Interface Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	45	45
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
Abdominal Pain	1	1
Death	1	1
No Code Available	1	1
Infection, Indirect	1	1
Bone Fracture(s)	1	1
Chemical Exposure	1	1
Osteopenia/ Osteoporosis	1	1
Disseminated Intravascular Coagulation (DIC)	1	1
Pain	1	1
Muscle/Tendon Damage	1	1
Renal Failure	1	1
Tachycardia	1	1
Toxicity	1	1
Hemorrhage/Bleeding	1	1
No Consequences Or Impact To Patient	1	1
Thromboembolism	1	1
Low Blood Pressure/ Hypotension	1	1
Respiratory Failure	1	1

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