Pump, Infusion, Enteral

Device Code: 2670

Product Code(s): LZH

Device Classification Information

Device Type ID2670
Device NamePump, Infusion, Enteral
Regulation DescriptionInfusion Pump.
Regulation Medical SpecialtyGeneral Hospital
Review PanelGeneral Hospital
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type510(k)
CFR Regulation Number880.5725 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeLZH
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID2670
DevicePump, Infusion, Enteral
Product CodeLZH
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionInfusion Pump.
CFR Regulation Number880.5725 [🔎]
Premarket Reviews
ManufacturerDecision
COVIDIEN
 
SUBSTANTIALLY EQUIVALENT
 3
MOOG, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
ZEVEX
 
SUBSTANTIALLY EQUIVALENT
 1
Device Problems
No Audible Alarm
 823
No Display / Image
 719
Loss Of Power
 563
Excess Flow Or Over-Infusion
 259
Device Alarm System
 188
Volume Accuracy Problem
 164
Leak / Splash
 158
Failure To Auto Stop
 132
Inaccurate Flow Rate
 129
Insufficient Flow Or Under Infusion
 127
Thermal Decomposition Of Device
 114
Protective Measures Problem
 108
Display Or Visual Feedback Problem
 99
Infusion Or Flow Problem
 53
Failure To Deliver
 50
Defective Alarm
 38
Detachment Of Device Component
 38
Detachment Of Device Or Device Component
 36
Delayed Alarm
 35
Improper Flow Or Infusion
 32
Overheating Of Device
 29
Inaccurate Delivery
28
Alarm
 25
Decreased Pump Speed
 25
Fluid Leak
 24
Pump
 24
Use Of Device Problem
 19
Increased Pump Speed
 15
Device Stops Intermittently
 14
Occlusion Within Device
 12
Melted
 9
Defective Component
 9
Disconnection
 9
Incorrect Or Inadequate Test Results
 8
Power Problem
 8
Incorrect Measurement
 7
Electrical Power Problem
 7
Programmer
 6
Free Or Unrestricted Flow
 6
Diode
 6
Failure To Infuse
 5
Device Handling Problem
 5
Break
 5
Improper Or Incorrect Procedure Or Method
 5
Battery Problem
 5
Fail-Safe Problem
 5
Device Displays Incorrect Message
5
Electrical /Electronic Property Problem
 4
Adverse Event Without Identified Device Or Use Problem
 4
Appropriate Term/Code Not Available
 4
Battery
 4
Sparking
 4
Device Operates Differently Than Expected
 4
Temperature Problem
 4
Insufficient Information
 4
Device Issue
 4
Power Cord
 4
Alarm Not Visible
3
Pumping Problem
 3
Complete Blockage
 3
Use Of Incorrect Control Settings
 3
Delivery System Failure
 3
Device Operational Issue
 3
Fire
 3
False Alarm
 3
Issue With Displayed Error Message
 3
Socket Adaptor
 3
Smoking
 3
Inadequate Lighting
 3
Output Below Specifications
 3
Screen
 2
Application Program Problem: Dose Calculation Error
 2
Output Above Specifications
 2
Physical Property Issue
 2
Corroded
2
Display Difficult To Read
2
Failure To Fire
2
Charging Problem
2
Difficult To Remove
2
Failure To Sense
2
Programming Issue
 2
Failure To Shut Off
 2
Output Problem
 2
Charred
 2
Noise, Audible
 2
Switch, Push Button
 2
Kinked
 2
Loose Or Intermittent Connection
 2
Failure To Disconnect
 2
Material Rupture
 2
Cassette
 2
Device Emits Odor
 2
Material Separation
 2
Partial Blockage
 2
Contamination Of Device Ingredient Or Reagent
 2
Device Contamination With Chemical Or Other Material
 2
Improper Alarm
 1
Material Deformation
 1
Reset Problem
 1
Electrical Shorting
 1
Total Device Problems 4325
Recalls
Manufacturer Recall Class Date Posted
1
Medtronic
 II May-10-2016
TPLC Last Update: 2019-04-02 20:17:09
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