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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device pump, infusion, pca
Regulation Description Infusion pump.
Product CodeMEA
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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