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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
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
  SUBSTANTIALLY EQUIVALENT 1
DEKA RESEARCH AND DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 4 4
2022 22 22
2023 61 61
2024 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 45 45
Device Contamination with Chemical or Other Material 8 8
Communication or Transmission Problem 6 6
Mechanical Problem 5 5
Fluid/Blood Leak 5 5
Use of Device Problem 4 4
Defective Device 4 4
Pumping Stopped 4 4
Device Displays Incorrect Message 4 4
Failure to Deliver 3 3
Patient Device Interaction Problem 3 3
Device Alarm System 3 3
Leak/Splash 2 2
Output Problem 2 2
Wireless Communication Problem 2 2
Battery Problem 2 2
Infusion or Flow Problem 2 2
Charging Problem 2 2
Connection Problem 2 2
Device Contaminated at the User Facility 2 2
Device Difficult to Setup or Prepare 1 1
Obstruction of Flow 1 1
No Apparent Adverse Event 1 1
Product Quality Problem 1 1
Detachment of Device or Device Component 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Audible Alarm 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Premature End-of-Life Indicator 1 1
Failure to Run on Battery 1 1
Pumping Problem 1 1
No Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 46 46
No Clinical Signs, Symptoms or Conditions 30 30
Dyspnea 9 9
Diarrhea 8 8
Nausea 7 7
Dizziness 6 6
Vomiting 6 6
Pain 4 4
Headache 4 4
Pulmonary Hypertension 3 3
Loss of consciousness 3 3
Low Oxygen Saturation 3 3
Respiratory Failure 3 3
Unspecified Infection 2 2
Menstrual Irregularities 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Fatigue 2 2
Diaphoresis 2 2
Erythema 2 2
Distress 2 2
Cyanosis 1 1
Pulmonary Dysfunction 1 1
Arthralgia 1 1
Presyncope 1 1
Inflammation 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Localized Skin Lesion 1 1
Peripheral Edema 1 1
Cellulitis 1 1
Electrolyte Imbalance 1 1
Confusion/ Disorientation 1 1
Chills 1 1
Pallor 1 1
Renal Impairment 1 1
Pneumonia 1 1
Anxiety 1 1
Swelling/ Edema 1 1
Hypoxia 1 1
Unspecified Respiratory Problem 1 1
Hypervolemia 1 1

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