TPLC - Total Product Life Cycle

• Device: system, peritoneal, automatic delivery
• Regulation Description: Peritoneal dialysis system and accessories.
• Product Code: FKX
• Regulation Number: 876.5630
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ABBOTT
	SUBSTANTIALLY EQUIVALENT	6
BAXTER HEALTHCARE CORP.
	SUBSTANTIALLY EQUIVALENT	6
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	2
DEKA RESEARCH & DEVELOPMENT CORP.
	SUBSTANTIALLY EQUIVALENT	1
FRESENIUS
	SUBSTANTIALLY EQUIVALENT	2
Lifemed of California
	SUBSTANTIALLY EQUIVALENT	1
ORGANON-TEKNIKA
	SUBSTANTIALLY EQUIVALENT	1
PHYSIO-CONTROL, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Fluid leak	388
Device displays error message	224
Overfill	149
Leak	80
Air leak	75
Disconnection	62
Improper or incorrect procedure or method	57
Component falling	50
No Information	46
No code available	41
Hole in material	29
Device operates differently than expected	21
Detachment of device component	18
Use of Device Issue	14
Break	10
No Known Device Problem	10
Contamination during use	7
Ultrafiltration	6
Excess flow or overinfusion	6
Cut in material	5
Detachment of device or device component	4
Dislodged or dislocated	4
Collapse	4
Component(s), broken	4
Material puncture	4
Failure to prime	4
Human-Device Interface Issue	4
Infusion or flow issue	4
Material separation	3
Alarm, audible	3
Device Difficult to Setup or Prepare	3
Volume accuracy issue	3
Loose or intermittent connection	3
Occlusion within device	2
Connection issue	2
Manufacturing or shipping issue associated with device	2
Grounding malfunction	2
Difficult to insert	2
Scratched material	2
Material rupture	2
Misconnection	2
Sticking	2
Nonstandard device or device component	2
Shipping damage or problem	2
Crack	2
Incorrect display	2
No flow	2
Smoking	2
Defective item	2
Blocked connection	2
Other (for use when an appropriate device code cannot be identified)	2
Unknown (for use when the device problem is not known)	2
Inaccurate delivery	2
Out-of-box failure	2
Difficult to remove	2
Unsealed device packaging	1
Inappropriate prompts	1
Use of Incorrect Control Settings	1
Failure to cycle	1
Fracture	1
Material twisted	1
Split	1
Improper flow or infusion	1
Packaging issue	1
Not Applicable	1
Filling problem	1
Mechanical issue	1
Not audible alarm	1
Slippage of device or device component	1
Suction issue	1
Reuse	1
Failure to Adhere or Bond	1
Defective component	1
Battery issue	1
Unintended collision	1
Material discolored	1
Kinked	1
Device alarm system issue	1
Burn of device or device component	1
Insufficient flow or underinfusion	1
Failure to spike	1
Perivalvular leak	1
Failure to reset	1
Misassembled	1
Total Device Problems	1418

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	1	0	0	0
Class II	0	1	0	1	2	2	1
Class III	0	0	0	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Baxter Healthcare Renal Div	II	Aug-02-2012
2	Baxter Healthcare Renal Div	II	Jul-06-2011
3	Baxter Healthcare Renal Div	II	May-03-2011
4	Baxter Healthcare Renal Div	I	Mar-01-2010
5	Baxter Healthcare Renal Div	II	Mar-07-2008
6	Fresenius Medical Care Holdings, Inc.	II	Feb-11-2013
7	Fresenius Medical Care Holdings, Inc.	II	Apr-24-2012
8	Fresenius Medical Care Holdings, Inc.	II	Oct-20-2010