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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device infusion pump, drug specific, pharmacy-filled
Regulation Description Infusion pump.
Definition A Pharmacy-Filled, Drug Specific Infusion System is a prescription device intended for delivery of a specific drug in accordance with the FDA approved labeling and may be filled at a location other than point of care.
Product CodeQJY
Regulation Number 880.5725
Device Class 2


Premarket Reviews
ManufacturerDecision
DEKA RESEARCH & DEVELOPMENT CORP.
  SUBSTANTIALLY EQUIVALENT 1
DEKA RESEARCH AND DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 4 9
2022 22 26
2023 61 62
2024 43 43
2025 155 155
2026 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 128 129
Communication or Transmission Problem 25 30
Infusion or Flow Problem 25 25
Fluid/Blood Leak 16 16
Use of Device Problem 13 15
Device Contamination with Chemical or Other Material 9 9
Connection Problem 8 8
Wireless Communication Problem 8 8
Obstruction of Flow 8 9
Battery Problem 8 8
Failure to Infuse 7 7
False Alarm 7 7
Intermittent Infusion 6 6
Defective Device 6 6
Leak/Splash 5 5
No Flow 5 5
Mechanical Problem 5 5
Excess Flow or Over-Infusion 5 5
Device Displays Incorrect Message 4 5
Charging Problem 4 4
Pumping Stopped 4 4
Patient Device Interaction Problem 4 4
Intermittent Communication Failure 3 3
Detachment of Device or Device Component 3 3
Failure to Pump 3 3
Failure to Deliver 3 3
Pumping Problem 3 3
Crack 3 3
Device Alarm System 3 5
Failure to Power Up 2 2
Device Difficult to Setup or Prepare 2 2
Contamination 2 2
No Audible Alarm 2 2
Therapeutic or Diagnostic Output Failure 2 7
Adverse Event Without Identified Device or Use Problem 2 2
Device Fell 2 2
Protective Measures Problem 2 2
Difficult to Open or Close 2 2
Premature Discharge of Battery 2 2
Output Problem 2 4
Break 2 2
Device Contaminated at the User Facility 2 2
Noise, Audible 2 2
Moisture Damage 1 1
Difficult or Delayed Activation 1 1
Vibration 1 1
Audible Prompt/Feedback Problem 1 1
Increased Sensitivity 1 1
Difficult or Delayed Separation 1 1
Labelling, Instructions for Use or Training Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 118 125
Insufficient Information 85 87
Dyspnea 33 35
Dizziness 20 20
Headache 18 18
Vomiting 16 16
Nausea 15 15
Pain 15 15
Diarrhea 14 14
Fatigue 9 9
Low Oxygen Saturation 7 10
Chest Pain 6 6
Erythema 5 5
Lethargy 5 5
Anxiety 5 5
Loss of consciousness 5 5
Swelling/ Edema 5 5
Pulmonary Hypertension 5 5
Diaphoresis 4 4
Low Blood Pressure/ Hypotension 4 4
Unspecified Infection 4 4
Hypoxia 3 3
Hot Flashes/Flushes 3 3
Itching Sensation 3 3
Tachycardia 3 3
Pallor 3 3
Presyncope 3 3
Respiratory Failure 3 3
Unspecified Kidney or Urinary Problem 3 3
Unspecified Respiratory Problem 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Hypersensitivity/Allergic reaction 2 2
Hypervolemia 2 2
Distress 2 2
Arthralgia 2 2
Menstrual Irregularities 2 2
Chills 2 2
Pneumonia 2 2
Rash 2 2
Inflammation 2 2
Cyanosis 2 2
Angina 1 1
Bradycardia 1 1
Bruise/Contusion 1 1
Cellulitis 1 1
Incontinence 1 1
Hemorrhage/Bleeding 1 1
Local Reaction 1 1
Red Eye(s) 1 1
Renal Failure 1 1

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