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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 adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
Product CodeDTL
Regulation Number 870.4290
Device Class 2


Premarket Reviews
ManufacturerDecision
GALT MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
THERAGENICS CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Leak / Splash 178
Tear, Rip or Hole in Device Packaging 23
Infusion or Flow Problem 17
Suction Problem 11
Device Contamination with Chemical or Other Material 10
Air Leak 9
Loose or Intermittent Connection 8
Physical Resistance / Sticking 8
Crack 8
Unable to Obtain Readings 7
Failure to Cycle 6
No Flow 6
Stopcock Valve 6
Material Integrity Problem 5
Adverse Event Without Identified Device or Use Problem 5
Difficult to Insert 4
Improper or Incorrect Procedure or Method 4
Use of Device Problem 4
Difficult to Advance 4
Device Operates Differently Than Expected 4
Improper Device Output 4
Fluid Leak 4
Defective Device 3
Delivered as Unsterile Product 3
Improper Flow or Infusion 2
Insufficient Flow or Under Infusion 2
Connection Problem 2
Gauges/Meters 2
Fracture 2
Hemo Valve 2
Suction Failure 2
Difficult to Remove 2
Difficult to Open or Close 1
Pressure Problem 1
Display or Visual Feedback Problem 1
No Apparent Adverse Event 1
Material Split, Cut or Torn 1
Off-Label Use 1
Disconnection 1
Flushing problem 1
Unstable 1
Device Damaged Prior to Use 1
Obstruction of Flow 1
Physical Resistance 1
Implant Mobility NOS (Not otherwise specified) 1
Adapter (Adaptor) 1
Mechanical Problem 1
Mechanical Jam 1
Material Separation 1
Missing Value Reason 1
Decoupling 1
Deflation Problem 1
Product Quality Problem 1
Total Device Problems 378

Recalls
Manufacturer Recall Class Date Posted
1 Cook Inc. II May-09-2018
2 LivaNova USA Inc. II Jun-26-2020
3 Medtronic Perfusion Systems II Jul-10-2017
4 Terumo Cardiovascular Systems Corp II Jun-23-2015
5 Terumo Cardiovascular Systems Corporation II Jun-21-2018
6 Vascular Solutions, Inc. I Apr-07-2016

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