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TPLC
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show TPLC since
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Device
pump, infusion, pca
Product Code
MEA
Regulation Number
880.5725
Device Class
2
Premarket Reviews
Manufacturer
Decision
B. BRAUN MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
HOSPIRA, INC
SUBSTANTIALLY EQUIVALENT
1
SMITHS MEDICAL ADS, INC.
SUBSTANTIALLY EQUIVALENT
1
SMITHS MEDICAL ASD, INC.
SUBSTANTIALLY EQUIVALENT
1
SUMMIT MEDICAL PRODUCTS, INC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
381
381
2015
99
99
2016
56
56
2017
43
43
2018
256
256
2019
131
131
2020
2331
2331
2021
3775
3775
2022
6443
6443
2023
3984
3984
2024
738
738
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
5977
5977
Crack
4449
4449
Corroded
3889
3889
Device Markings/Labelling Problem
3869
3869
Failure to Align
2482
2482
Contamination
1630
1630
Appropriate Term/Code Not Available
987
987
Device Alarm System
943
943
Deformation Due to Compressive Stress
848
848
Physical Resistance/Sticking
784
784
No Apparent Adverse Event
721
721
Naturally Worn
664
664
Inaccurate Delivery
610
610
Failure to Calibrate
600
600
Device Sensing Problem
570
570
Display Difficult to Read
563
563
Computer Software Problem
517
517
Circuit Failure
382
382
Excess Flow or Over-Infusion
363
363
Misassembled
353
353
Insufficient Information
275
275
Calibration Problem
249
249
Application Program Freezes, Becomes Nonfunctional
245
245
Degraded
240
240
Insufficient Flow or Under Infusion
224
224
Volume Accuracy Problem
206
206
Infusion or Flow Problem
179
179
Failure to Analyze Signal
178
178
Communication or Transmission Problem
150
150
Display or Visual Feedback Problem
150
150
Failure to Read Input Signal
117
117
Device Displays Incorrect Message
112
112
Failure to Sense
94
94
Failure to Deliver
92
92
Device Inoperable
76
76
Occlusion Within Device
70
70
Fluid/Blood Leak
58
58
Use of Device Problem
53
53
Obstruction of Flow
50
50
No Audible Alarm
49
49
Electrical /Electronic Property Problem
47
47
Mechanical Problem
45
45
Loss of Power
45
45
Air/Gas in Device
45
45
Audible Prompt/Feedback Problem
44
44
Output Problem
42
42
Component Misassembled
42
42
Inaccurate Flow Rate
42
42
Improper Flow or Infusion
39
39
Battery Problem
38
38
Connection Problem
36
36
Pumping Stopped
36
36
Material Integrity Problem
30
30
Leak/Splash
28
28
No Display/Image
28
28
Application Program Problem
27
27
False Alarm
26
26
Failure to Power Up
26
26
Peeled/Delaminated
25
25
Adverse Event Without Identified Device or Use Problem
25
25
Fail-Safe Problem
25
25
Failure to Infuse
21
21
Component Missing
21
21
Missing Information
19
19
Defective Alarm
18
18
Contamination /Decontamination Problem
17
17
Loose or Intermittent Connection
16
16
Mechanics Altered
15
15
Device Operates Differently Than Expected
14
14
Defective Component
14
14
Product Quality Problem
13
13
Power Problem
13
13
No Flow
12
12
Improper or Incorrect Procedure or Method
12
12
Device Misassembled During Manufacturing /Shipping
12
12
Increase in Pressure
10
10
Complete Blockage
10
10
Failure to Cycle
10
10
Application Program Problem: Medication Error
10
10
Pressure Problem
10
10
Device Difficult to Maintain
9
9
Partial Blockage
9
9
Thermal Decomposition of Device
9
9
Incorrect Measurement
8
8
Nonstandard Device
8
8
Device Slipped
8
8
Detachment of Device or Device Component
8
8
Loss of Data
8
8
Defective Device
8
8
Blocked Connection
8
8
Pumping Problem
8
8
Programming Issue
7
7
Application Program Version or Upgrade Problem
7
7
Failure to Pump
7
7
Incorrect, Inadequate or Imprecise Result or Readings
7
7
Failure to Charge
7
7
Smoking
6
6
Noise, Audible
6
6
Intermittent Loss of Power
6
6
Inaccurate Information
6
6
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
13027
13027
No Patient Involvement
3695
3695
Insufficient Information
967
967
No Consequences Or Impact To Patient
337
339
No Known Impact Or Consequence To Patient
272
272
No Information
175
175
Pain
33
33
Overdose
24
24
Death
20
20
Not Applicable
13
13
Oversedation
9
9
Inadequate Pain Relief
7
7
Low Oxygen Saturation
6
6
Decreased Respiratory Rate
6
6
Cardiac Arrest
6
6
Fall
6
6
Low Blood Pressure/ Hypotension
6
6
Dizziness
5
5
Underdose
5
5
Numbness
4
4
Cardiopulmonary Arrest
4
4
Hypoglycemia
4
4
Nausea
4
4
High Blood Pressure/ Hypertension
3
3
Bradycardia
3
3
Loss of consciousness
3
3
Lethargy
3
3
No Code Available
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Syncope/Fainting
2
2
Diaphoresis
2
2
Coma
2
2
Anxiety
2
2
Dyspnea
2
2
Hypoxia
2
2
Respiratory Distress
2
2
Brain Injury
2
2
Tachycardia
2
2
Under no medication
1
1
Blurred Vision
1
1
Vomiting
1
1
Convulsion, Clonic
1
1
Therapeutic Response, Increased
1
1
Shock
1
1
Overmedicated
1
1
Neurological Deficit/Dysfunction
1
1
Ischemia
1
1
Muscle Weakness
1
1
Fatigue
1
1
Fever
1
1
Gastritis
1
1
Chest Pain
1
1
Bruise/Contusion
1
1
Aneurysm
1
1
Apnea
1
1
Discomfort
1
1
Complaint, Ill-Defined
1
1
Injury
1
1
Hypoesthesia
1
1
Extubate
1
1
Increased Respiratory Rate
1
1
Chest Tightness/Pressure
1
1
Pallor
1
1
Paresthesia
1
1
Pulmonary Hypertension
1
1
Respiratory Insufficiency
1
1
Unspecified Respiratory Problem
1
1
Missed Dose
1
1
Treatment with medication(s)
1
1
Hospitalization required
1
1
Decreased Sensitivity
1
1
Patient Problem/Medical Problem
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
B Braun Medical Inc
II
Mar-22-2022
2
Baxter Healthcare Corp.
II
Apr-27-2015
3
CareFusion 303, Inc.
II
Jan-08-2018
4
Hospira Inc.
II
Sep-22-2016
5
Hospira Inc.
II
Jul-08-2016
6
Hospira Inc.
II
Apr-23-2015
7
Hospira, Inc.
II
Sep-10-2012
8
Smiths Medical ASD Inc.
II
Feb-01-2018
9
Smiths Medical ASD, Inc.
II
Mar-10-2017
10
Smiths Medical ASD, Inc.
II
Jun-18-2015
11
Smiths Medical ASD, Inc.
II
Nov-01-2014
12
Smiths Medical ASD, Inc.
II
Oct-04-2011
13
Smiths Medical ASD, Inc.
II
Feb-03-2011
14
Smiths Medical ASD, Inc.
II
Mar-11-2010
15
Stryker Instruments Div. of Stryker Corporation
II
Sep-03-2010
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