TPLC - Total Product Life Cycle

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

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

MDR Year	MDR Reports	MDR Events
2018	3	3
2019	9	9
2020	21	21
2021	17	17
2022	11	11
2023	13	13

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fracture	29	29
Appropriate Term/Code Not Available	12	12
Crack	11	11
Detachment of Device or Device Component	6	6
Material Puncture/Hole	5	5
Burst Container or Vessel	5	5
Fluid/Blood Leak	5	5
Break	3	3
Leak/Splash	3	3
Loose or Intermittent Connection	3	3
Material Integrity Problem	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Therapeutic or Diagnostic Output Failure	1	1
Device Markings/Labelling Problem	1	1
Filtration Problem	1	1
Product Quality Problem	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Defective Component	1	1
Tear, Rip or Hole in Device Packaging	1	1
Particulates	1	1
Material Frayed	1	1
Restricted Flow rate	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	30	30
No Clinical Signs, Symptoms or Conditions	28	28
Insufficient Information	10	10
No Patient Involvement	3	3
Muscle/Tendon Damage	1	1
Pain	1	1
Chemical Exposure	1	1