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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tubing, pump, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass pump tubing.
Product CodeDWE
Regulation Number 870.4390
Device Class 2


Premarket Reviews
ManufacturerDecision
ANGIODYNAMICS COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Leak / Splash 57
Fluid Leak 47
Device Operates Differently Than Expected 29
Defective Component 17
Filtration Problem 16
Improper Flow or Infusion 15
Device Misassembled During Manufacturing / Shipping 10
Infusion or Flow Problem 8
Misassembled 8
Adverse Event Without Identified Device or Use Problem 6
Pumping Problem 5
Packaging Problem 5
Crack 5
Restricted Flow rate 5
Malfunction 5
Material Fragmentation 5
Kinked 5
Use of Device Problem 4
Detachment Of Device Component 4
Loose or Intermittent Connection 4
Noise, Audible 4
No Flow 4
No Apparent Adverse Event 3
Material Discolored 3
Disconnection 3
Air Leak 3
Improper or Incorrect Procedure or Method 3
Device Contamination with Chemical or Other Material 3
Device Displays Incorrect Message 3
Blocked Connection 3
Connection Problem 2
Device Markings / Labelling Problem 2
Device Sensing Problem 2
Labeling, missing 2
Shipping Damage or Problem 2
Device Damaged Prior to Use 2
Component Missing 2
Jaw 2
Component(s), broken 2
Decoupling 2
Cap 2
Luer Valve 2
Port 2
Tube 2
Fracture 2
Particulates 2
Increase in Pressure 2
Off-Label Use 2
Pumping Stopped 2
Pressure Problem 2
Insufficient Information 1
Appropriate Term/Code Not Available 1
Physical Property Issue 1
Output Problem 1
Torn Material 1
One-Way Valve 1
Misassembly by Users 1
Difficult to Remove 1
Failure to Analyze Signal 1
Misconnection 1
Delivered as Unsterile Product 1
Occlusion Within Device 1
No Device Output 1
Unsealed Device Packaging 1
False Device Output 1
Incorrect Measurement 1
Migration or Expulsion of Device 1
Coil 1
Filter 1
Shaft 1
Transducer 1
Loss of or Failure to Bond 1
Break 1
Complete Blockage 1
Clumping in Device or Device Ingredient 1
Device Contamination with Body Fluid 1
Tear, Rip or Hole in Device Packaging 1
Obstruction of Flow 1
Sticking 1
Inadequate or Insufficient Training 1
Tube(s), splitting of 1
Other (for use when an appropriate device code cannot be identified) 1
Laser pulse timing error 1
Defective Device 1
Difficult to Open or Close 1
Free or Unrestricted Flow 1
Improper Device Output 1
Manufacturing, Packaging or Shipping Problem 1
Mechanics Altered 1
Total Device Problems 371

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics Inc. (Navilyst Medical Inc.) II May-20-2016
2 Datascope Corporation II Oct-11-2018
3 Datascope Corporation III Jun-06-2018
4 Datascope Corporation II May-08-2018
5 Datascope Corporation II Mar-23-2017
6 Datascope Corporation II Jun-15-2016
7 LivaNova USA III Feb-21-2018
8 Maquet II Dec-20-2017
9 Medtronic Inc. Cardiac Rhythm Disease Management II Feb-20-2014
10 Medtronic Perfusion Systems II Sep-04-2015
11 Sorin Group USA, Inc. II Jul-29-2017

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