TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
ADVANCED INFUSION, INC.
	SUBSTANTIALLY EQUIVALENT	5
APEX
	SUBSTANTIALLY EQUIVALENT	1
B. BRAUN MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
BAXTER HEALTHCARE CORP.
	SUBSTANTIALLY EQUIVALENT	8
BIOMET
	SUBSTANTIALLY EQUIVALENT	1
ETHICON
	SUBSTANTIALLY EQUIVALENT	1
GO MEDICAL INDUSTRIES PTY. LTD.
	SUBSTANTIALLY EQUIVALENT	1
I FLOW CORP
	SUBSTANTIALLY EQUIVALENT	16
IMED CORP.
	SUBSTANTIALLY EQUIVALENT	1
LEVENTON, S.A.
	SUBSTANTIALLY EQUIVALENT	1
McKinley Medical, LLP
	SUBSTANTIALLY EQUIVALENT	3
MEDICAL FLOW SYSTEMS LTD
	SUBSTANTIALLY EQUIVALENT	1
NIPRO CORP
	SUBSTANTIALLY EQUIVALENT	1
ORTHOFIX
	SUBSTANTIALLY EQUIVALENT	5
SYMBIOS MEDICAL PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	3
TANDEM MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
VLV ASSOCIATES, INC.
	SE SUBJECT TO TRACKING REG	1
WELCH ALLYN, INC.
	SUBSTANTIALLY EQUIVALENT	3
WESTMED, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Excess flow or overinfusion	92
Material rupture	87
Fluid leak	52
Break	13
Detachment of device component	6
Disconnection	4
Leak	4
Filling problem	4
Unknown (for use when the device problem is not known)	3
Burst	3
Component missing	3
Reflux within device	3
Slippage of device or device component	2
No Information	2
Torn material	2
Device damaged prior to use	2
Crack	2
Improper or incorrect procedure or method	1
Shaft break	1
Material deformation	1
Loose or intermittent connection	1
Tube(s), defective	1
No flow	1
Failure to deliver	1
Split	1
Fracture	1
Infusion or flow issue	1
Device, or device fragments remain in patient	1
Material fragmentation	1
Total Device Problems	296

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	3	2	2
Class II	1	3	2	1	3	0	0
Class III	0	0	0	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Baxter Healthcare Corp.	II	May-05-2011
2	Baxter Healthcare Corp.	II	Jan-23-2008
3	First Medical Source LLC	I	Oct-30-2012
4	Hsmg, Inc. D/b/a Smartinfuser Usa	II	Apr-14-2011
5	Hsmg, Inc. D/b/a Smartinfuser Usa	II	Mar-08-2010
6	I-Flow Corporation	I	Aug-28-2012
7	I-Flow Corporation	II	Jul-28-2011
8	I-Flow Corporation	II	Sep-14-2009
9	I-Flow Corporation	II	Sep-11-2008
10	I-Flow Corporation	II	Sep-11-2008
11	I-Flow Corporation	II	Jan-18-2007
12	Progressive Medical Inc	I	Oct-24-2011
13	Stryker Instruments Div. of Stryker Corporation	II	Sep-04-2009
14	Symbios Medical Products, LLC	I	Jun-06-2013
15	Symbios Medical Products, LLC	I	Mar-13-2013
16	Victus, Inc.	I	Oct-24-2011
17	Wolf Medical Supply Inc.	I	Nov-23-2011