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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
AIDERA AB
  SUBSTANTIALLY EQUIVALENT 2
AMERICAN I.V. PRODUCTS, INC DBA AIV, INC
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN I.V. PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
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
HOSPIRA, INC
  SUBSTANTIALLY EQUIVALENT 1
ICU MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
IVWATCH, LLC
  SUBSTANTIALLY EQUIVALENT 1
LIFESCAN, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITHS MEDICAL MD, INC.
  SUBSTANTIALLY EQUIVALENT 1
WELLDOC, INC
  SUBSTANTIALLY EQUIVALENT 6
WELLDOC, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 117 117
2016 55 55
2017 18 18
2018 46 46
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
Break 139 139
Device Alarm System 42 42
Excess Flow or Over-Infusion 20 20
Adverse Event Without Identified Device or Use Problem 17 17
Power Problem 17 17
Fluid/Blood Leak 15 15
Thermal Decomposition of Device 14 14
Computer Software Problem 13 13
Infusion or Flow Problem 13 13
Patient Device Interaction Problem 13 13
Insufficient Flow or Under Infusion 12 12
Charging Problem 9 9
Protective Measures Problem 9 9
Mechanical Problem 9 9
Temperature Problem 8 8
Electrical /Electronic Property Problem 7 7
Smoking 6 6
Battery Problem 6 6
Device Issue 6 6
Device Displays Incorrect Message 5 5
Material Integrity Problem 5 5
Failure to Power Up 5 5
Leak/Splash 4 4
Melted 4 4
Failure to Charge 4 4
Volume Accuracy Problem 4 4
Air/Gas in Device 4 4
Packaging Problem 3 3
Appropriate Term/Code Not Available 3 3
Defective Device 3 3
Sparking 3 3
Improper Flow or Infusion 3 3
Device Contamination with Chemical or Other Material 3 3
Display or Visual Feedback Problem 3 3
Product Quality Problem 3 3
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Use of Device Problem 2 2
Overheating of Device 2 2
Difficult To Position 2 2
Failure to Prime 2 2
No Audible Alarm 2 2
Inaccurate Flow Rate 2 2
Crack 2 2
Free or Unrestricted Flow 2 2
Output Problem 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
Insufficient Information 2 2
Key or Button Unresponsive/not Working 1 1
Failure to Eject 1 1
Physical Resistance/Sticking 1 1
Audible Prompt/Feedback Problem 1 1
Inadequate Lubrication 1 1
Detachment of Device or Device Component 1 1
Device Damaged by Another Device 1 1
Electrical Shorting 1 1
Failure to Auto Stop 1 1
Flare or Flash 1 1
Split 1 1
Arcing 1 1
Defective Component 1 1
Failure to Deliver 1 1
Inaccurate Delivery 1 1
Failure to Infuse 1 1
Therapeutic or Diagnostic Output Failure 1 1
Problem with Software Installation 1 1
Failure to Cycle 1 1
Difficult or Delayed Positioning 1 1
Corroded 1 1
Image Display Error/Artifact 1 1
Bent 1 1
Defective Alarm 1 1
Low Audible Alarm 1 1
Charred 1 1
Complete Blockage 1 1
Material Puncture/Hole 1 1
Inaccurate Synchronization 1 1
Device Inoperable 1 1
Failure to Sense 1 1
Material Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 111 111
No Consequences Or Impact To Patient 104 104
No Clinical Signs, Symptoms or Conditions 68 68
No Patient Involvement 58 58
Insufficient Information 48 48
Electric Shock 24 24
No Information 19 19
Pain 6 6
Erythema 5 5
Swelling/ Edema 5 5
Loss of consciousness 3 3
Death 3 3
Endocarditis 2 2
Overdose 2 2
Hyperglycemia 2 2
High Blood Pressure/ Hypertension 2 2
Unspecified Infection 2 2
Blood Loss 1 1
Hypoglycemia 1 1
Headache 1 1
Vomiting 1 1
Fainting 1 1
Inadequate Pain Relief 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Code Available 1 1
Chemical Exposure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Animas Corporation II Dec-03-2009
2 ICU Medical Inc II Oct-14-2019
3 ICU Medical Inc II Dec-17-2018
4 Smiths Medical ASD Inc. II Apr-15-2024
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