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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
Fluid/Blood Leak 5 5
Mechanical Problem 5 5
Pumping Stopped 4 4
Device Displays Incorrect Message 4 4
Defective Device 4 4
Use of Device Problem 4 4
Patient Device Interaction Problem 3 3
Failure to Deliver 3 3
Device Alarm System 3 3
Leak/Splash 2 2
Device Contaminated at the User Facility 2 2
Battery Problem 2 2
Infusion or Flow Problem 2 2
Charging Problem 2 2
Output Problem 2 2
Wireless Communication Problem 2 2
Connection Problem 2 2
No Audible Alarm 1 1
No Flow 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Difficult to Setup or Prepare 1 1
Obstruction of Flow 1 1
Adverse Event Without Identified Device or Use Problem 1 1
No Apparent Adverse Event 1 1
Detachment of Device or Device Component 1 1
Product Quality Problem 1 1
Premature End-of-Life Indicator 1 1
Failure to Run on Battery 1 1
Pumping Problem 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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