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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
MDR Year
MDR Reports
MDR Events
2020
2331
2331
2021
3776
3776
2022
6443
6443
2023
3985
3985
2024
4560
4560
2025
1899
1899
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
6346
6346
Crack
4684
4684
Corroded
4027
4027
Device Markings/Labelling Problem
3935
3935
Failure to Align
2511
2511
Contamination
1789
1789
Deformation Due to Compressive Stress
1700
1700
Device Alarm System
1436
1436
Device Sensing Problem
1303
1303
Failure to Infuse
1031
1031
Appropriate Term/Code Not Available
996
996
Physical Resistance/Sticking
867
867
Inaccurate Delivery
796
796
No Apparent Adverse Event
746
746
Naturally Worn
726
726
Failure to Calibrate
691
691
Degraded
639
639
Display Difficult to Read
579
579
Circuit Failure
531
531
Computer Software Problem
527
527
Failure to Sense
484
484
Calibration Problem
387
387
Excess Flow or Over-Infusion
376
376
Misassembled
355
355
Peeled/Delaminated
348
348
Insufficient Information
323
323
Application Program Freezes, Becomes Nonfunctional
246
246
Insufficient Flow or Under Infusion
234
234
Volume Accuracy Problem
222
222
Failure to Read Input Signal
207
207
Failure to Analyze Signal
178
178
Improper Flow or Infusion
165
165
Display or Visual Feedback Problem
161
161
Communication or Transmission Problem
156
156
Air/Gas in Device
133
133
Detachment of Device or Device Component
132
132
Inaccurate Flow Rate
128
128
Obstruction of Flow
127
127
Infusion or Flow Problem
113
113
Material Integrity Problem
100
100
False Alarm
94
94
Mechanical Problem
93
93
Wireless Communication Problem
88
88
Defective Component
76
76
Use of Device Problem
76
76
Pumping Stopped
75
75
Connection Problem
67
67
Electrical /Electronic Property Problem
66
66
Material Split, Cut or Torn
66
66
Failure to Deliver
63
63
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
18391
18391
No Patient Involvement
3371
3371
Insufficient Information
1315
1315
No Consequences Or Impact To Patient
88
88
No Information
78
78
Pain
30
30
No Known Impact Or Consequence To Patient
16
16
Cardiac Arrest
11
11
Increased Respiratory Rate
7
7
Low Oxygen Saturation
6
6
Fall
6
6
Oversedation
6
6
Low Blood Pressure/ Hypotension
5
5
Nausea
5
5
Hypoglycemia
4
4
Numbness
4
4
Lethargy
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Dizziness
3
3
Underdose
3
3
Decreased Respiratory Rate
2
2
Headache
2
2
Inadequate Pain Relief
2
2
Bradycardia
2
2
Dyspnea
2
2
Taste Disorder
2
2
Hypersensitivity/Allergic reaction
2
2
Syncope/Fainting
2
2
High Blood Pressure/ Hypertension
2
2
Pallor
1
1
Paralysis
1
1
Vomiting
1
1
Fever
1
1
Discomfort
1
1
Vertigo
1
1
Chest Pain
1
1
Diarrhea
1
1
Injury
1
1
Coma
1
1
Paresthesia
1
1
Overdose
1
1
Peripheral Edema
1
1
Reaction to Medicinal Component of Device
1
1
Swelling/ Edema
1
1
Tachycardia
1
1
Muscle Weakness
1
1
Hypoxia
1
1
Unspecified Respiratory Problem
1
1
Ulcer
1
1
Diaphoresis
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
B Braun Medical Inc
II
Mar-22-2022
2
Smiths Medical ASD Inc.
I
Aug-03-2024
3
Smiths Medical ASD, Inc.
I
May-07-2025
4
Smiths Medical ASD, Inc.
I
May-07-2025
5
Smiths Medical ASD, Inc.
I
May-05-2025
6
Smiths Medical ASD, Inc.
II
Nov-15-2024
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