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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
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
WELLDOC, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 36 36
2020 44 44
2021 59 59
2022 39 39
2023 27 27
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Device Alarm System 37 37
Fluid/Blood Leak 15 15
Computer Software Problem 13 13
Patient Device Interaction Problem 13 13
Infusion or Flow Problem 13 13
Insufficient Flow or Under Infusion 12 12
Protective Measures Problem 9 9
Excess Flow or Over-Infusion 9 9
Charging Problem 7 7
Mechanical Problem 6 6
Break 5 5
Material Integrity Problem 5 5
Battery Problem 4 4
Volume Accuracy Problem 4 4
Air/Gas in Device 4 4
Leak/Splash 3 3
Device Contamination with Chemical or Other Material 3 3
Thermal Decomposition of Device 3 3
Defective Device 3 3
Packaging Problem 3 3
Display or Visual Feedback Problem 3 3
Improper Flow or Infusion 3 3
Device Displays Incorrect Message 3 3
Connection Problem 2 2
Activation, Positioning or Separation Problem 2 2
Obstruction of Flow 2 2
Failure to Calibrate 2 2
No Audible Alarm 2 2
Product Quality Problem 2 2
Power Problem 2 2
Inaccurate Flow Rate 2 2
Communication or Transmission Problem 2 2
Output Problem 2 2
Crack 2 2
Insufficient Information 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Free or Unrestricted Flow 2 2
Audible Prompt/Feedback Problem 1 1
Defective Alarm 1 1
Overheating of Device 1 1
Inaccurate Delivery 1 1
Detachment of Device or Device Component 1 1
Low Audible Alarm 1 1
Physical Resistance/Sticking 1 1
Image Display Error/Artifact 1 1
Complete Blockage 1 1
Problem with Software Installation 1 1
Failure to Sense 1 1
Failure to Cycle 1 1
Inaccurate Synchronization 1 1
Failure to Prime 1 1
Defective Component 1 1
Failure to Eject 1 1
Appropriate Term/Code Not Available 1 1
Material Puncture/Hole 1 1
Smoking 1 1
Therapeutic or Diagnostic Output Failure 1 1
Failure to Auto Stop 1 1
Inadequate Lubrication 1 1
Key or Button Unresponsive/not Working 1 1
Electrical /Electronic Property Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 68 68
Insufficient Information 48 48
No Consequences Or Impact To Patient 42 42
No Patient Involvement 17 17
No Information 16 16
No Known Impact Or Consequence To Patient 7 7
Pain 6 6
Swelling/ Edema 5 5
Erythema 5 5
High Blood Pressure/ Hypertension 2 2
Unspecified Infection 2 2
Overdose 2 2
Endocarditis 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Headache 1 1
Hyperglycemia 1 1
Inadequate Pain Relief 1 1
Chemical Exposure 1 1
Blood Loss 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ICU Medical Inc II Oct-14-2019
2 Smiths Medical ASD Inc. II Apr-15-2024
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