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TPLC - Total Product Life Cycle
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Device pump, infusion
Regulation Description Infusion pump.
Product CodeFRN
Regulation Number 880.5725
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 8
ABBOTT
  SUBSTANTIALLY EQUIVALENT 69
  1.  K000821  ABBOTT GEMSTAR I.V. INFUSION PUMP - 7 THERAPY CONF ...
  2.  K002126  ABBOTT ACCLAIM ENCORE STANDARD TUBING PUMP
  3.  K010924  MODIFICATION TO PLUM XL INFUSION PUMP
  4.  K011096  ABBOTT ACCLAIM ENCORE, MODEL 12237
  5.  K011442  ABBOTT PLUM A+INFUSION PUMP, MODEL 11971
  6.  K021350  ABBOTT PLUM A+3 MULTICHANNEL INFUSION PUMP, MODEL ...
  7.  K023062  GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY ...
  8.  K024084  ABBOTT PLUM A+ INFUSION PUMP, MODEL 12391
  9.  K031185  ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AN ...
  10.  K040114  ABBOTT DATA PORT PC, MODEL 12181
  11.  K041550  HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNE ...
  12.  K770087  I.V. PUMP, ABBOTT/SHAW LIFECARE
  13.  K772094  LIFECARE I.V. PUMP - MODEL III
  14.  K791528  FLEXIFO ENTERAL NUTRITION PUMP
  15.  K801441  ABBOTT/SHAW LIFE CARE PUMP MODEL 3
  16.  K821661  FLEXIFLO-II
  17.  K830452  PCA PUMP
  18.  K831203  Y-TYPE BACKCHECK MICROBORE EXTEN. SET
  19.  K832120  PROMINJET PUMP
  20.  K832289  LIFECARE MICRO PUMP
  21.  K840263  LIFECARE 4/HOMECARE - 4H PUMP
  22.  K841784  FLEXIFLO-III PORTABLE ENTERAL NUTRI
  23.  K844091  ABBOTT LIFECARE 900 VOLUMETRIC PUMP
  24.  K844768  ABBOTT LIFECARE 500 INFUSER
  25.  K863997  ABBOTT LIFECARE(R) 4100 PCA INFUSER
  26.  K865058  ABBOTT LIFECARE (R) 5000, PUMP SYSTEM
  27.  K865059  I.V. SET W/SINGLE-CHANNEL CASSETTE
  28.  K865060  I.V. SET WITH DUAL-CHANNEL CASSETTE
  29.  K871728  MODIFIED LIFECARE(R) 4100 PCA INFUSER
  30.  K883645  LIFECARE MICRO PUMP
  31.  K883796  LIFECARE MICRO PUMP
  32.  K890282  RESUBMITTED ABBOTT LIFECARE MODEL 3 HB PUMP
  33.  K893769  LIFECARE MICRO PUMP (INFUSION PUMP)
  34.  K895709  ABBOTT PATIENT CONTROLLED ANALGESIA (PCA) PUMP
  35.  K895710  ABBOTT LIFECARE 4100 PCA INFUSER
  36.  K895867  PANCRETEC I.V. MODEL 5000 INFUSER
  37.  K900057  LIFECARE(R) 175 INFUSER
  38.  K900467  LIFECARE MODEL 4 PUMP
  39.  K900468  LIFECARE(R) MODEL 3 PUMP
  40.  K902432  AMBULATORY INFUSER AND ASSOC. FLOW CONTROLLING SET
  41.  K910919  ABBOTT LIFECARE 5000 PUMP MODIFIED
  42.  K911401  ABBOTT LIFECARE 5000 PUMP
  43.  K911964  MODIFIED PANCRETEC PROVIDER ONE INFUSION SYSTEM
  44.  K912092  MODIFIED LIFECARE MODEL 175 INFUSER
  45.  K912928  LIFECARE 4100 PCA INFUSER PLUS II
  46.  K913718  PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED
  47.  K913719  PANCRETEC I.V. MODEL 5500 INFUSER
  48.  K913720  PANCRETEC PROVIDER ONE INFUSION SYSTEM, MODIFIED
  49.  K913931  PANCRETEC PROVIDER(R) MODEL 5500 INFUS PUMP, MODIF
  50.  K914349  PROVIDER APM INFUSION PUMP
  51.  K922702  PROVIDER ANNE INFUSER
  52.  K923601  PANCRETEC PROVIDER INFUSION PUMP -- MODIFICAITON
  53.  K923829  LIFECARE 175 INFUSER -- MODIFICATION
  54.  K931375  ABBOTT PLUM XL INFUSION PUMP
  55.  K933825  ADI SYSTEM
  56.  K934671  HI-FLO INFUSION PUMP
  57.  K944125  ABBOTT LTE INFUSION PUMP
  58.  K944190  LIFECARE 175 INFUSER, MODIFICATION
  59.  K944669  FLEXIFLO QUANTUM ENTERAL PUMP
  60.  K944733  PLUM XL INFUSION PUMP
  61.  K952799  ABBOTT XL3M INFUSION PUMP
  62.  K953660  PLUM XL INFUSION PUMP (MODIFICATION)
  63.  K953731  PANCRETEC PROVIDER APM INFUSION PUMP (MODIFICATION ...
  64.  K965230  ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP
  65.  K974778  ABBOTT GEMSTAR IV INFUSION PUMP
  66.  K982159  ABBOTT PLUM A+ INFUSION PUMP
  67.  K983838  ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP
  68.  K991501  ACCLAIM INFUSION PUMP
  69.  K994039  ABBOTT GEMSTAR I.V. INFUSION PUMP-7 THERAPY CONFIG ...
ALARIS MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 7
AMERICAN I.V. PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANGIODYNAMICS, INC.
  SE SUBJECT TO TRACKING REG 1
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 12
BAXA CORP.
  SUBSTANTIALLY EQUIVALENT 2
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 41
BELMONT INSTRUMENT CORP.
  SE SUBJECT TO TRACKING REG 1
  SUBSTANTIALLY EQUIVALENT 3
BIOSEARCH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
BYRON MEDICAL
  SE SUBJECT TO TRACKING REG 1
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 22
CAESAREA MEDICAL ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 8
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 6
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
DEFINITIVE MEDICAL TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
DELPHI MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
DIATEK, INC.
  SUBSTANTIALLY EQUIVALENT 2
DISETRONIC MEDICAL SYSTEMS, INC.
  SE SUBJECT TO TRACKING REG 3
  SUBSTANTIALLY EQUIVALENT 5
ELIXIR CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ETHOX INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 3
E-Z-EM, INC.
  SUBSTANTIALLY EQUIVALENT 1
FLUIDSENSE CORP
  SUBSTANTIALLY EQUIVALENT 2
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 1
GO MEDICAL INDUSTRIES PTY. LTD.
  SUBSTANTIALLY EQUIVALENT 1
GRASEBY MEDICAL LTD.
  SE SUBJECT TO TRACKING REG 2
  SUBSTANTIALLY EQUIVALENT 2
GUIDANT CORP
  SUBSTANTIALLY EQUIVALENT 8
HAEMONETICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
HARVARD APPARATUS, INC.
  SUBSTANTIALLY EQUIVALENT 6
HARVARD CLINICAL TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
HK SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
HOSPIRA, INC.
  SUBSTANTIALLY EQUIVALENT 9
I FLOW CORP
  SUBSTANTIALLY EQUIVALENT 13
ICU MEDICAL SALES, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMED CORP.
  SUBSTANTIALLY EQUIVALENT 22
INTERMEDICS
  SUBSTANTIALLY EQUIVALENT 7
IRADIMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
KOLSTER METHODS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAMMENDORFER INSTITUTE FOR PHYSICS & MEDICINE GMBH
  SUBSTANTIALLY EQUIVALENT 1
MARQUETTE
  SUBSTANTIALLY EQUIVALENT 2
McKinley Medical, LLP
  SUBSTANTIALLY EQUIVALENT 3
MEDEX
  SE SUBJECT TO TRACKING REG 2
  SUBSTANTIALLY EQUIVALENT 4
MEDFUSION, INC.
  SUBSTANTIALLY EQUIVALENT 5
MEDRAD, INC.
  SUBSTANTIALLY EQUIVALENT 6
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 15
METTLER ELECTRONICS CORP.
  SE SUBJECT TO TRACKING REG 1
MINNESOTA MINING AND MFG. CO.
  SE SUBJECT TO TRACKING REG 1
MIRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 1
NORFOLK MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
NOUVAG AG
  SUBSTANTIALLY EQUIVALENT 1
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 2
PEREGRINE SURGICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
PROMEDIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
Q-CORE, LTD
  SUBSTANTIALLY EQUIVALENT 1
QUEST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
SABRATEK
  SUBSTANTIALLY EQUIVALENT 4
SIGMA
  SUBSTANTIALLY EQUIVALENT 6
SIMS
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SE SUBJECT TO TRACKING REG 1
  SUBSTANTIALLY EQUIVALENT 1
SMITHS
  SUBSTANTIALLY EQUIVALENT 12
SORENSON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 7
SUNRISE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
SYNERGETICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 1
VALLEYLAB
  SUBSTANTIALLY EQUIVALENT 7
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 3
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ZYNO MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Component(s), broken 2454
Battery failure 1698
Device displays error message 1608
Device inoperable 852
Not audible alarm 748
Defective component 672
Excess flow or overinfusion 614
Failure to deliver 533
Failure to sense 376
Alarm, audible 334
Insufficient flow or underinfusion 314
Inaccurate flowrate 280
Break 273
Fluid leak 243
Overdelivery 234
Occlusion within device 228
Infusion or flow issue 192
Device alarm system issue 185
Underdelivery 140
Device operates differently than expected 138
Use of Device Issue 135
Loss of power 125
Bent 121
Spark 106
Incorrect software programming calculations 94
Charred 88
Inaccurate delivery 85
Calibration error 83
Material separation 82
Free or unrestricted flow 72
Improper flow or infusion 65
Pressure sensor failure 63
Bubble detector, failure of 61
Air leak 59
Self-activation or keying 57
Malfunction 53
Reflux within device 46
Unknown (for use when the device problem is not known) 43
Melted 38
Calibration issue 37
Pumping stopped 36
Smoking 36
Failure to power-up 36
Accuracy rate 32
Burn of device or device component 32
No Known Device Problem 31
Sticking 31
Other (for use when an appropriate device code cannot be identified) 30
Disconnection 28
Defective Alarm 26
Failure to infuse 26
Battery issue 24
False alarm 24
Sensor problems 24
Fire 23
Electrical issue 19
Material rupture 16
Slippage of device or device component 15
Device stops intermittently 14
Shock, electrical 13
Pumping issue 13
Failure to prime 12
Leak 12
Computer software issue 11
Restricted flowrate 10
Particulates 10
Mechanical issue 10
Valve(s), failure of 10
Size incorrect for patient 9
Crack 9
Volume accuracy issue 9
Inappropriate prompts 8
Incorrect display 7
Increased pump speed 7
Failure to pump 7
Component missing 6
Defective item 6
Deployment issue 6
No Information 6
Delivery system failure 5
Hole in material 5
Use of Incorrect Control Settings 4
Improper or incorrect procedure or method 4
Foreign material present in device 4
Failure to calibrate 4
Failure to shut off 4
No display or display failure 4
Overheating of device or device component 3
No flow 3
Not Applicable 3
Circuit Failure 3
Low battery 3
Arcing 3
Poor quality image 3
Blank screen 3
Failure to deploy 3
Programming issue 3
Tears, rips, holes in device, device material 3
Device Issue 3
Dissatisfaction 2
Total Device Problems 14385

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 3 1 2 7 4 8 3
Class II 6 9 10 9 20 14 3
Class III 1 0 0 0 1 2 0

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics, INC II Nov-17-2010
2 B Braun Medical, Inc I Oct-18-2011
3 B Braun Medical, Inc II Oct-03-2011
4 B Braun Medical, Inc I Jan-10-2011
5 B. Braun Medical, Inc. II Dec-31-2012
6 B. Braun Medical, Inc. I Jul-16-2012
7 B. Braun Medical, Inc. I Feb-29-2012
8 B. Braun Medical, Inc. II Sep-23-2008
9 Baxter Healthcare Corp. III Aug-24-2012
10 Baxter Healthcare Corp. II Jan-13-2012
11 Baxter Healthcare Corp. II Jan-11-2012
12 Baxter Healthcare Corp. II Oct-28-2011
13 Baxter Healthcare Corp. II Aug-11-2011
14 Baxter Healthcare Corp. II Aug-11-2011
15 Baxter Healthcare Corp. II Aug-08-2011
16 Baxter Healthcare Corp. II Jul-19-2011
17 Baxter Healthcare Corp. II Jul-13-2011
18 Baxter Healthcare Corp. II May-19-2011
19 Baxter Healthcare Corp. II Apr-29-2011
20 Baxter Healthcare Corp. III Feb-18-2011
21 Baxter Healthcare Corp. II Jan-21-2011
22 Baxter Healthcare Corp. II Jan-21-2011
23 Baxter Healthcare Corp. II Jan-21-2011
24 Baxter Healthcare Corp. I Oct-12-2010
25 Baxter Healthcare Corp. I Mar-02-2009
26 Baxter Healthcare Corp. II Oct-21-2008
27 Baxter Healthcare Corp. I Sep-19-2007
28 Baxter Healthcare Corp. I Jul-28-2007
29 Baxter Healthcare Corp. I Jul-18-2007
30 Baxter Healthcare Corp. II Mar-20-2007
31 Baxter Healthcare Corp. II Jan-11-2007
32 Belmont Instrument Corporation II Oct-12-2012
33 Cardinal Health 303 Inc DBA Alaris Products II Jun-10-2008
34 Cardinal Health 303 Inc DBA Alaris Products I Jan-04-2008
35 Cardinal Health 303 Inc DBA Alaris Products II Aug-03-2007
36 Cardinal Health 303 Inc DBA Alaris Products II Aug-02-2007
37 Cardinal Health 303 dba Cardinal Health I Aug-03-2009
38 Cardinal Health 303 dba Cardinal Health II May-01-2009
39 Cardinal Health 303 dba Cardinal Health II Apr-07-2009
40 CareFusion 303, Inc. I Aug-17-2012
41 CareFusion 303, Inc. I Aug-15-2012
42 CareFusion 303, Inc. I Jul-26-2012
43 CareFusion 303, Inc. II Jan-26-2012
44 CareFusion Corporation I Oct-13-2010
45 Carefusion Corporation I Apr-15-2013
46 Carefusion Corporation II Apr-15-2013
47 Curlin Medical Llc II Sep-22-2008
48 Hospira Inc II Mar-08-2011
49 Hospira Inc I Oct-22-2010
50 Hospira Inc II Sep-09-2010
51 Hospira Inc I Sep-08-2010
52 Hospira Inc I Jul-02-2010
53 Hospira Inc II Oct-06-2009
54 Hospira Inc II Aug-11-2009
55 Hospira Inc II Feb-27-2009
56 Hospira Inc. I Apr-30-2013
57 Hospira Inc. I Apr-26-2013
58 Hospira Inc. II Apr-15-2013
59 Hospira Inc. II Dec-31-2012
60 Hospira Inc. II Dec-07-2012
61 Hospira Inc. I Oct-19-2012
62 Hospira Inc. II May-04-2012
63 Hospira Inc. II Apr-26-2012
64 Hospira Inc. II Oct-04-2011
65 Hospira Inc. II Sep-29-2011
66 Hospira Inc. II Aug-31-2011
67 Hospira Inc. II Apr-15-2011
68 Hospira Inc. II Mar-14-2011
69 Hospira Inc. II Mar-08-2011
70 Hospira Inc. II Aug-17-2010
71 Iradimed Corporation II Nov-28-2012
72 MOOG Medical Devices Group II Oct-17-2012
73 MOOG Medical Devices Group II Apr-13-2012
74 Medrad Inc II Dec-20-2012
75 Medtronic Emergency Response Systems, Inc. II Jun-21-2007
76 Roche Insulin Delivery Systems Inc. I Mar-10-2011
77 Sigma III Jul-18-2012
78 Sigma I Jun-13-2012
79 Sigma International General Medical Apparatus, Llc I Nov-05-2010
80 Smiths Medical ASD, Inc. II Mar-26-2013
81 Smiths Medical ASD, Inc. I Aug-01-2012
82 Smiths Medical ASD, Inc. II Mar-14-2012
83 Smiths Medical ASD, Inc. II Aug-02-2010
84 Smiths Medical ASD, Inc. II Apr-05-2010
85 Smiths Medical ASD, Inc. II Jan-15-2010
86 Smiths Medical MD, Inc. II Mar-09-2009
87 Smiths Medical MD, Inc. II Sep-23-2008
88 Smiths Medical MD, Inc. II Aug-24-2008
89 Smiths Medical MD, Inc. II Aug-15-2008
90 Smiths Medical MD, Inc. II Feb-26-2008
91 Smiths Medical MD, Inc. II Feb-13-2008
92 Smiths Medical MD, Inc. II Apr-26-2007
93 Smiths Medical MD, Inc. III Apr-05-2007
94 Stryker Instruments Div. of Stryker Corporation II Oct-20-2010
95 Stryker Instruments Div. of Stryker Corporation II Sep-28-2010
96 Stryker Instruments Div. of Stryker Corporation II Sep-03-2010
97 Stryker Instruments Div. of Stryker Corporation II Aug-19-2009
98 Stryker Instruments Div. of Stryker Corporation II Apr-30-2009
99 Stryker Instruments Div. of Stryker Corporation II Feb-02-2009
100 Stryker Instruments Div. of Stryker Corporation II Jan-27-2009
101 Walkmed Infusion LLC I Nov-05-2010
102 Zevex International, Inc. I Apr-05-2011
103 Zevex International, Inc. II Feb-25-2011

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