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TPLC
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Device
pump, infusion, pca
Regulation Description
Infusion pump.
Product Code
MEA
Regulation Number
880.5725
Device Class
2
Premarket Reviews
Manufacturer
Decision
HOSPIRA, INC
SUBSTANTIALLY EQUIVALENT
1
HOSPIRA, INC.
SUBSTANTIALLY EQUIVALENT
1
SUMMIT MEDICAL PRODUCTS, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2016
56
56
2017
43
43
2018
257
257
2019
130
130
2020
2312
2312
Device Problems
MDRs with this Device Problem
Events in those MDRs
Crack
1458
1458
Break
1216
1216
Device Markings/Labelling Problem
970
970
Corroded
527
527
Deformation Due to Compressive Stress
434
434
Appropriate Term/Code Not Available
417
417
Naturally Worn
307
307
Misassembled
205
205
Excess Flow or Over-Infusion
156
156
Device Sensing Problem
144
144
Pump
137
137
No Apparent Adverse Event
115
115
Infusion or Flow Problem
114
114
Degraded
109
109
Display or Visual Feedback Problem
107
107
Computer Software Problem
98
98
Physical Resistance/Sticking
93
93
Failure to Analyze Signal
88
88
Insufficient Flow or Under Infusion
85
85
Circuit Failure
81
81
Failure to Calibrate
81
81
Contamination
73
73
Device Displays Incorrect Message
70
70
Inaccurate Delivery
51
51
Device Alarm System
47
47
Volume Accuracy Problem
43
43
Application Program Freezes, Becomes Nonfunctional
40
40
Failure to Read Input Signal
30
30
Insufficient Information
29
29
Fluid Leak
17
17
Calibration Problem
17
17
Electrical /Electronic Property Problem
15
15
Alarm
14
14
Battery Problem
13
13
Communication or Transmission Problem
13
13
Improper Flow or Infusion
12
12
Cassette
11
11
Adverse Event Without Identified Device or Use Problem
10
10
False Alarm
10
10
Inaccurate Flow Rate
10
10
Device Operates Differently Than Expected
9
9
Failure to Power Up
9
9
Use of Device Problem
8
8
Sensor
8
8
Battery
8
8
Improper or Incorrect Procedure or Method
8
8
Failure to Infuse
7
7
Occlusion Within Device
7
7
Display Difficult to Read
7
7
Pumping Stopped
7
7
Output Problem
7
7
Mechanics Altered
6
6
Increase in Pressure
5
5
Pressure Problem
5
5
Connection Problem
5
5
Noise, Audible
5
5
Loss of Power
5
5
Component Missing
5
5
Application Program Problem
5
5
Charred
5
5
Failure to Cycle
4
4
Application Program Version or Upgrade Problem
4
4
No Display/Image
4
4
Application Program Problem: Medication Error
4
4
No Flow
4
4
Device Contamination with Chemical or Other Material
4
4
Leak/Splash
4
4
Power Cord
4
4
Defective Alarm
4
4
Missing Information
4
4
Complete Loss of Power
3
3
Alarm, Visual
3
3
Loose or Intermittent Connection
3
3
Material Discolored
3
3
Device Inoperable
3
3
Programming Issue
3
3
Failure to Deliver
3
3
Device Slipped
3
3
Smoking
3
3
Computer System Security Problem
3
3
Failure to Align
3
3
Filling Problem
3
3
Adapter (Adaptor)
2
2
Seal
2
2
Tube
2
2
Failure to Charge
2
2
Lenses
2
2
No Audible Alarm
2
2
Delivery System Failure
2
2
Inaccurate Dispensing
2
2
Difficult to Open or Close
2
2
Inaccurate Synchronization
2
2
Incorrect, Inadequate or Imprecise Resultor Readings
2
2
Failure to Sense
2
2
Obstruction of Flow
2
2
Protective Measures Problem
2
2
Temperature Problem
2
2
Activation Problem
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Material Integrity Problem
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
2282
2282
No Known Impact Or Consequence To Patient
196
196
No Consequences Or Impact To Patient
185
186
No Information
143
143
Not Applicable
13
13
Overdose
13
13
Pain
10
10
Death
8
8
No Clinical Signs, Symptoms or Conditions
7
7
Underdose
4
4
Dizziness
4
4
Cardiac Arrest
3
3
High Blood Pressure/ Hypertension
3
3
Low Blood Pressure/ Hypotension
3
3
Low Oxygen Saturation
2
2
Oversedation
2
2
Insufficient Information
2
2
Respiratory Distress
2
2
Anxiety
2
2
Inadequate Pain Relief
2
2
No Code Available
2
2
Chest Tightness/Pressure
1
1
Patient Problem/Medical Problem
1
1
Complaint, Ill-Defined
1
1
Brain Injury
1
1
Convulsion, Clonic
1
1
Shock
1
1
Tachycardia
1
1
Blurred Vision
1
1
Bradycardia
1
1
Hypoxia
1
1
Nausea
1
1
Decreased Respiratory Rate
1
1
Decreased Sensitivity
1
1
Coma
1
1
Diaphoresis
1
1
Pallor
1
1
Ischemia
1
1
Neurological Deficit/Dysfunction
1
1
Aneurysm
1
1
Cardiopulmonary Arrest
1
1
Dyspnea
1
1
Fatigue
1
1
Gastritis
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
CareFusion 303, Inc.
II
Jan-08-2018
2
Hospira Inc.
II
Sep-22-2016
3
Hospira Inc.
II
Jul-08-2016
4
Smiths Medical ASD Inc.
II
Feb-01-2018
5
Smiths Medical ASD, Inc.
II
Mar-10-2017
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