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U.S. Department of Health and Human Services

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

MDR Year MDR Reports MDR Events
2021 3776 3798
2022 6443 6449
2023 3984 3990
2024 4559 4564
2025 3330 3330
2026 1755 1755

Device Problems MDRs with this Device Problem Events in those MDRs
Break 5327 5329
Corroded 3539 3542
Crack 3461 3462
Device Markings/Labelling Problem 2963 2963
Failure to Align 2520 2520
Contamination 1739 1742
Failure to Infuse 1678 1678
Device Sensing Problem 1592 1592
Device Alarm System 1536 1539
Deformation Due to Compressive Stress 1313 1313
Inaccurate Delivery 917 921
Physical Resistance/Sticking 804 804
Failure to Sense 707 707
Degraded 666 667
No Apparent Adverse Event 663 664
Failure to Calibrate 616 622
Appropriate Device Problem Term/Code Not Available 573 573
Display Difficult to Read 554 554
Circuit Failure 526 526
Calibration Problem 478 488
Excess Flow or Over-Infusion 455 460
Naturally Worn 439 439
Computer Software Problem 419 419
Peeled/Delaminated 382 382
Insufficient Flow or Under Infusion 292 294
Insufficient Device Problem Information 289 290
Detachment of Device or Device Component 230 230
Failure to Read Input Signal 223 225
Volume Accuracy Problem 220 223
Obstruction of Flow 218 218
Application Program Freezes or Fails to Launch 206 206
Improper Flow or Infusion 203 203
Air/Gas in Device 167 168
Inaccurate Flow Rate 157 157
Misassembled 151 151
Communication or Transmission Problem 145 145
Complete Blockage 127 127
Mechanical Problem 126 126
False Alarm 124 124
Material Split, Cut or Torn 115 115
Electrical /Electronic Property Problem 113 114
Material Integrity Problem 108 108
Defective Component 107 107
Wireless Communication Problem 107 107
Use of Device Problem 103 105
Pressure Problem 103 103
Infusion or Flow Problem 95 97
Failure to Analyze Signal 89 89
Failure to Deliver 85 86
Loose or Intermittent Connection 82 82

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 21442 21476
Insufficient Information 1363 1378
No Patient Involvement 1185 1185
Pain 47 48
No Consequences Or Impact To Patient 20 21
No Information 19 19
Cardiac Arrest 10 10
Low Blood Pressure/ Hypotension 8 8
Oversedation 8 8
Increased Respiratory Rate 7 7
Numbness 7 7
Nausea 6 6
Fall 6 6
Lethargy 4 4
Low Oxygen Saturation 4 5
Inadequate Pain Relief 4 4
Hypoglycemia 4 4
Dyspnea 4 4
Pulmonary Hypertension 3 3
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 3 3
Dizziness 3 3
Decreased Level of Consciousness 2 2
Decreased Respiratory Rate 2 2
Loss of consciousness 2 2
Headache 2 2
Hypoxia 2 2
Asystole 2 2
Discomfort 2 2
Vomiting 2 2
Taste Disorder 2 2
Respiratory Arrest 2 2
Diaphoresis 2 2
Hypersensitivity/Allergic reaction 2 2
Apnea 2 2
Syncope/Fainting 2 3
Chest Pain 1 1
Diarrhea 1 1
Vertigo 1 1
Pallor 1 1
Paralysis 1 1
Awareness during Anaesthesia 1 1
Hemorrhage/Blood Loss/Bleeding 1 1
Coma 1 1
Sleepiness/Drowsiness/Somnolence 1 1
Fever 1 1
Paresthesia 1 1
Bradycardia 1 1
Peripheral Edema 1 1
Tachycardia 1 1
Swelling/ Edema 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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