• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device accessories, pump, infusion
Regulation Description Infusion pump.
Product CodeMRZ
Regulation Number 880.5725
Device Class 2


Premarket Reviews
ManufacturerDecision
B. BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MELSUGEN AG
  SUBSTANTIALLY EQUIVALENT 1
CHENGDU SHIFENG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ICU MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
WELLDOC, INC
  SUBSTANTIALLY EQUIVALENT 2
WELLDOC, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 18 18
2018 46 46
2019 36 36
2020 44 44
2021 58 58

Device Problems MDRs with this Device Problem Events in those MDRs
Device Alarm System 34 34
Thermal Decomposition of Device 14 14
Fluid Leak 14 14
Excess Flow or Over-Infusion 14 14
Insufficient Flow or Under Infusion 12 12
Infusion or Flow Problem 12 12
Power Problem 9 9
Charging Problem 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Mechanical Problem 8 8
Electrical /Electronic Property Problem 6 6
Device Issue 6 6
Patient Device Interaction Problem 6 6
Failure to Power Up 5 5
Break 5 5
Leak/Splash 4 4
Volume Accuracy Problem 4 4
Device Displays Incorrect Message 4 4
Protective Measures Problem 4 4
Battery Problem 3 3
Smoking 3 3
Incorrect, Inadequate or Imprecise Resultor Readings 2 2
Failure to Prime 2 2
Use of Device Problem 2 2
Obstruction of Flow 2 2
Display or Visual Feedback Problem 2 2
Crack 2 2
No Audible Alarm 2 2
Failure to Charge 2 2
Insufficient Information 2 2
Air/Gas in Device 2 2
Output Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Defective Device 2 2
Improper Flow or Infusion 2 2
Communication or Transmission Problem 2 2
Connection Problem 2 2
Activation, Positioning or SeparationProblem 2 2
Detachment of Device or Device Component 1 1
Device Damaged by Another Device 1 1
Failure to Auto Stop 1 1
Flare or Flash 1 1
Free or Unrestricted Flow 1 1
Problem with Software Installation 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Failure to Eject 1 1
Charred 1 1
Complete Blockage 1 1
Corroded 1 1
Defective Alarm 1 1
Low Audible Alarm 1 1
Failure to Cycle 1 1
Difficult or Delayed Positioning 1 1
Melted 1 1
Overheating of Device 1 1
Failure to Calibrate 1 1
Split 1 1
Arcing 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Failure to Sense 1 1
Device Inoperable 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 87 87
Insufficient Information 30 30
No Clinical Signs, Symptoms or Conditions 23 23
No Patient Involvement 21 21
No Information 18 18
No Known Impact Or Consequence To Patient 14 14
Loss of consciousness 3 3
Death 3 3
Endocarditis 2 2
Hyperglycemia 2 2
High Blood Pressure/ Hypertension 2 2
Overdose 2 2
Electric Shock 2 2
Blood Loss 1 1
Inadequate Pain Relief 1 1
Pain 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 ICU Medical Inc II Dec-17-2018
-
-