TPLC - Total Product Life Cycle

• Device: supplies, blood-bank
• Product Code: KSS
• Regulation Number: 864.9050
• Device Class: 1

Premarket Reviews
Manufacturer	Decision
FRESENIUS KABI AG
	SUBSTANTIALLY EQUIVALENT	1
FRESENIUS KABI USA LLC.
	SUBSTANTIALLY EQUIVALENT	1
ITL CORPORATION PTY, LTD
	SUBSTANTIALLY EQUIVALENT	1
MACOPRODUCTIONS S.A.S.
	SUBSTANTIALLY EQUIVALENT	2
TIMESTRIP UK LTD.
	SUBSTANTIALLY EQUIVALENT	2
TYPENEX MEDICAL LLC
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	6	6
2015	1	1
2016	8	8
2017	3	3
2018	10	10
2019	11	11
2020	2	2
2021	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Difficult to Setup or Prepare	7	7
Insufficient Information	5	5
Separation Problem	4	4
Fracture	3	3
Delivered as Unsterile Product	2	2
Mechanical Problem	2	2
Incorrect Or Inadequate Test Results	2	2
Inadequacy of Device Shape and/or Size	2	2
Leak/Splash	2	2
Separation Failure	2	2
False Negative Result	2	2
Material Separation	1	1
Pressure Problem	1	1
Break	1	1
Crack	1	1
Improper Flow or Infusion	1	1
Output Problem	1	1
Noise, Audible	1	1
Filling Problem	1	1
Fluid/Blood Leak	1	1
Shipping Damage or Problem	1	1
Particulates	1	1
Appropriate Term/Code Not Available	1	1
Device Operational Issue	1	1
Tear, Rip or Hole in Device Packaging	1	1
Material Integrity Problem	1	1
Contamination	1	1
Device Contamination with Body Fluid	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Information	10	10
No Code Available	8	8
No Patient Involvement	8	8
No Known Impact Or Consequence To Patient	7	7
No Consequences Or Impact To Patient	5	5
Unspecified Infection	3	3
Laceration(s)	2	2
No Clinical Signs, Symptoms or Conditions	2	2
Pain	1	1
Swelling	1	1