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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device accessories, pump, infusion
Regulation Description Infusion pump.
Product CodeMRZ
Regulation Number 880.5725
Device Class 2


Premarket Reviews
ManufacturerDecision
CHENGDU SHIFENG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ELITE BIOMEDICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
GILERO, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 61 66
2022 39 55
2023 27 27
2024 41 41
2025 37 37
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 49 49
Device Alarm System 26 26
Failure to Infuse 16 16
Computer Software Problem 14 14
Patient Device Interaction Problem 10 10
Intermittent Communication Failure 7 7
Material Integrity Problem 5 5
Overheating of Device 4 4
Battery Problem 3 3
Air/Gas in Device 3 3
Break 3 3
Packaging Problem 3 3
Circuit Failure 2 2
Device Contamination with Chemical or Other Material 2 2
Communication or Transmission Problem 2 2
Loose or Intermittent Connection 2 2
Power Problem 2 2
Insufficient Device Problem Information 2 2
Mechanical Problem 2 2
Failure to Calibrate 1 1
Device Emits Odor 1 1
Problem with Software Installation 1 1
Audible Prompt/Feedback Problem 1 2
Electrical /Electronic Property Problem 1 1
Electrical Shorting 1 1
Product Quality Problem 1 1
Crack 1 1
Smoking 1 1
Telemetry Discrepancy 1 1
Failure to Sense 1 1
Volume Accuracy Problem 1 1
Failure to Eject 1 1
Image Display Error/Artifact 1 1
Failure to Cycle 1 1
Pumping Stopped 1 1
Appropriate Device Problem Term/Code Not Available 1 1
Excess Flow or Over-Infusion 1 1
Inaccurate Synchronization 1 1
Insufficient Flow or Under Infusion 1 1
Infusion or Flow Problem 1 1
Fluid/Blood Leak 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 138 145
Insufficient Information 50 63
No Information 5 5
Pain 5 5
Swelling/ Edema 5 5
Erythema 5 5
No Patient Involvement 3 3
Unspecified Infection 2 2
Endocarditis 2 2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 1 2
No Consequences Or Impact To Patient 1 1
Headache 1 1
Bradycardia 1 1
Low Blood Pressure/ Hypotension 1 1
Tachycardia 1 1
Chemical Exposure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Smiths Medical ASD Inc. II Apr-15-2024
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