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