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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Device Alarm System 37 37
Fluid/Blood Leak 15 15
Patient Device Interaction Problem 13 13
Computer Software 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
Air/Gas in Device 4 4
Battery Problem 4 4
Volume Accuracy Problem 4 4
Device Contamination with Chemical or Other Material 3 3
Thermal Decomposition of Device 3 3
Display or Visual Feedback Problem 3 3
Device Displays Incorrect Message 3 3
Defective Device 3 3
Improper Flow or Infusion 3 3
Packaging Problem 3 3
Leak/Splash 3 3
Connection Problem 2 2
Failure to Calibrate 2 2
No Audible Alarm 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Power Problem 2 2
Product Quality Problem 2 2
Free or Unrestricted Flow 2 2
Obstruction of Flow 2 2
Inaccurate Flow Rate 2 2
Activation, Positioning or Separation Problem 2 2
Communication or Transmission Problem 2 2
Overheating of Device 2 2
Insufficient Information 2 2
Wireless Communication Problem 2 2
Crack 2 2
Output Problem 2 2
Inadequate Lubrication 1 1
Failure to Sense 1 1
Electrical /Electronic Property Problem 1 1
Smoking 1 1
Defective Component 1 1
Physical Resistance/Sticking 1 1
Therapeutic or Diagnostic Output Failure 1 1
Failure to Eject 1 1
Material Puncture/Hole 1 1
Inaccurate Synchronization 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 72 72
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
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
Chemical Exposure 1 1
Blood Loss 1 1
Hyperglycemia 1 1
Headache 1 1
Inadequate Pain Relief 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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