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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 1

MDR Year MDR Reports MDR Events
2021 4 4
2022 22 22
2023 61 61
2024 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 41 41
Communication or Transmission Problem 6 6
Device Contamination with Chemical or Other Material 6 6
Fluid/Blood Leak 5 5
Mechanical Problem 4 4
Pumping Stopped 4 4
Use of Device Problem 4 4
Defective Device 4 4
Device Displays Incorrect Message 4 4
Failure to Deliver 3 3
Device Alarm System 3 3
Patient Device Interaction Problem 3 3
Device Contaminated at the User Facility 2 2
Connection Problem 2 2
Wireless Communication Problem 2 2
Infusion or Flow Problem 2 2
Output Problem 2 2
Leak/Splash 2 2
Battery Problem 2 2
Charging Problem 2 2
Obstruction of Flow 1 1
Product Quality Problem 1 1
No Audible Alarm 1 1
Failure to Run on Battery 1 1
Premature End-of-Life Indicator 1 1
Device Difficult to Setup or Prepare 1 1
Pumping Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
No Flow 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 45 45
No Clinical Signs, Symptoms or Conditions 28 28
Diarrhea 8 8
Dyspnea 8 8
Nausea 7 7
Vomiting 6 6
Dizziness 6 6
Pain 4 4
Headache 4 4
Loss of consciousness 3 3
Low Oxygen Saturation 3 3
Respiratory Failure 3 3
Diaphoresis 2 2
Distress 2 2
Menstrual Irregularities 2 2
Pulmonary Hypertension 2 2
Erythema 2 2
Fatigue 2 2
Hypoxia 1 1
Unspecified Infection 1 1
Inflammation 1 1
Pneumonia 1 1
Pulmonary Dysfunction 1 1
Electrolyte Imbalance 1 1
Anxiety 1 1
Chills 1 1
Renal Impairment 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Swelling/ Edema 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Arthralgia 1 1
Confusion/ Disorientation 1 1
Hypervolemia 1 1
Presyncope 1 1

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