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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
B. BRAUN MELSUGEN AG
  SUBSTANTIALLY EQUIVALENT 1
CHENGDU SHIFENG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ELITE BIOMEDICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
GILERO, LLC
  SUBSTANTIALLY EQUIVALENT 1
WELLDOC, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 44 44
2021 59 59
2022 39 39
2023 27 27
2024 38 38
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Device Alarm System 37 37
Wireless Communication Problem 26 26
Computer Software Problem 14 14
Infusion or Flow Problem 13 13
Patient Device Interaction Problem 10 10
Excess Flow or Over-Infusion 7 7
Protective Measures Problem 6 6
Break 5 5
Material Integrity Problem 5 5
Failure to Infuse 5 5
Volume Accuracy Problem 4 4
Air/Gas in Device 4 4
Overheating of Device 4 4
Charging Problem 4 4
Insufficient Flow or Under Infusion 4 4
Battery Problem 4 4
Mechanical Problem 4 4
Device Contamination with Chemical or Other Material 3 3
Device Displays Incorrect Message 3 3
Improper Flow or Infusion 3 3
Display or Visual Feedback Problem 3 3
Defective Device 3 3
Insufficient Information 3 3
Packaging Problem 3 3
Fluid/Blood Leak 3 3
Communication or Transmission Problem 2 2
Circuit Failure 2 2
Inaccurate Flow Rate 2 2
Failure to Calibrate 2 2
Problem with Software Installation 2 2
Intermittent Communication Failure 2 2
Product Quality Problem 2 2
Activation, Positioning or Separation Problem 2 2
Leak/Splash 2 2
Free or Unrestricted Flow 2 2
Power Problem 2 2
No Audible Alarm 2 2
Crack 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Output Problem 2 2
Failure to Sense 1 1
Loose or Intermittent Connection 1 1
Defective Component 1 1
Appropriate Term/Code Not Available 1 1
Failure to Cycle 1 1
Electrical /Electronic Property Problem 1 1
Physical Resistance/Sticking 1 1
Low Audible Alarm 1 1
Complete Blockage 1 1
Audible Prompt/Feedback Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 104 104
Insufficient Information 48 48
No Consequences Or Impact To Patient 19 19
No Patient Involvement 15 15
No Information 13 13
Pain 6 6
Swelling/ Edema 5 5
Erythema 5 5
No Known Impact Or Consequence To Patient 2 2
High Blood Pressure/ Hypertension 2 2
Unspecified Infection 2 2
Endocarditis 2 2
Overdose 2 2
Headache 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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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