TPLC - Total Product Life Cycle

• Device: pump, infusion, enteral
• Regulation Description: Infusion pump.
• Product Code: LZH
• Regulation Number: 880.5725
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ABBOTT
	SE SUBJECT TO TRACKING REG	1
	SUBSTANTIALLY EQUIVALENT	3
BAXTER HEALTHCARE CORP.
	SUBSTANTIALLY EQUIVALENT	1
CAESAREA MEDICAL ELECTRONICS
	SUBSTANTIALLY EQUIVALENT	1
KENDALL
	SE SUBJECT TO TRACKING REG	1
	SUBSTANTIALLY EQUIVALENT	1
ROSS PRODUCT DIV. ABBOTT LABORATORIES
	SE SUBJECT TO TRACKING REG	1
TYCO HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Component(s), broken	1658
Underdelivery	136
Failure to prime	134
Insufficient flow or underinfusion	70
Overdelivery	38
Other (for use when an appropriate device code cannot be identified)	35
Excess flow or overinfusion	28
Device alarm system issue	21
Break	15
Electrical issue	15
Inaccurate delivery	14
Power source issue	12
Arcing	8
Component missing	8
Low battery	7
No Information	7
Melted	7
Fire	5
Cut in material	5
Smoking	5
Battery issue	4
False alarm	4
Alarm, audible	4
Not audible alarm	3
Burn of device or device component	3
No display or display failure	3
Loose or intermittent connection	3
Implant Mobility NOS (Not otherwise specified)	3
Pumping stopped	3
Spark	2
No Known Device Problem	2
Motor drive unit (MDU) stalled or jammed	2
Overheating of device or device component	2
Loss of power	2
Blockage within device or device component	2
Shock, electrical	2
Alarm not visible	2
Adaptor, failure of	2
Alarm, failure of low flow	1
Balloon rupture	1
Battery failure	1
Blank screen	1
Incorrect display	1
Compatibility	1
Use of Incorrect Control Settings	1
Crack	1
Disconnection	1
Leak	1
Fluid leak	1
Image display error	1
Failure to power-up	1
Mechanical issue	1
Motor failure	1
No code available	1
Applicator failure	1
Device operates differently than expected	1
Expulsion	1
Pumping issue	1
Device displays error message	1
Fuse, blown	1
Device inoperable	1
Failure to pump	1
Failure to deliver	1
Tube(s), defective	1
Total Device Problems	2302

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

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott Laboratories	II	Sep-20-2008
2	Abbott Nutrition, Abbott Laboratories	II	Sep-21-2009
3	CORPAK MedSystems	II	Oct-25-2011
4	MOOG Medical Devices Group	II	Jan-31-2013
5	MOOG Medical Devices Group	II	Nov-15-2012
6	Ross Products Division Abbott Laboratories	II	Aug-08-2007
7	Ross Products Division Abbott Laboratories	II	Aug-07-2007
8	Zevex International, Inc.	II	Sep-21-2009