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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device probe, thermodilution
Product CodeKRB
Regulation Number 870.1915
Device Class 2


Premarket Reviews
ManufacturerDecision
PULSION MEDICAL SYSTEMS SE
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 18 18
2019 26 26
2020 16 16
2021 22 22
2022 21 21
2023 13 13
2024 30 30

Device Problems MDRs with this Device Problem Events in those MDRs
Break 38 38
Material Fragmentation 28 28
Leak/Splash 27 27
Fluid/Blood Leak 11 11
Incorrect Measurement 10 10
Adverse Event Without Identified Device or Use Problem 6 6
Difficult to Insert 5 5
Material Integrity Problem 4 4
Fracture 4 4
Crack 3 3
Detachment of Device or Device Component 3 3
Connection Problem 3 3
Uncoiled 3 3
Disconnection 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Material Rupture 2 2
Sticking 2 2
Appropriate Term/Code Not Available 2 2
Material Frayed 1 1
Improper Device Output 1 1
Entrapment of Device 1 1
Incomplete or Missing Packaging 1 1
Device Alarm System 1 1
Insufficient Information 1 1
Defective Device 1 1
Manufacturing, Packaging or Shipping Problem 1 1
False Reading From Device Non-Compliance 1 1
Unable to Obtain Readings 1 1
Stretched 1 1
Material Twisted/Bent 1 1
Misconnection 1 1
Packaging Problem 1 1
Retraction Problem 1 1
Device Operates Differently Than Expected 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 70 70
No Consequences Or Impact To Patient 40 40
No Known Impact Or Consequence To Patient 12 12
Foreign Body In Patient 6 6
Ischemia 4 4
Insufficient Information 4 4
Device Embedded In Tissue or Plaque 4 4
Hemorrhage/Bleeding 3 3
Infarction, Cerebral 2 2
Vascular Dissection 2 2
Shock 2 2
Air Embolism 1 1
Occlusion 1 1
No Information 1 1
Hematoma 1 1
Thrombosis 1 1
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ICU Medical, Inc. II Dec-22-2018
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