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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
2017 24 24
2018 18 18
2019 26 26
2020 16 16
2021 22 22
2022 21 21
2023 13 13
2024 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Break 38 38
Material Fragmentation 28 28
Leak/Splash 26 26
Incorrect Measurement 10 10
Difficult to Insert 8 8
Crack 8 8
Uncoiled 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Sticking 4 4
Material Integrity Problem 4 4
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Entrapment of Device 3 3
Material Rupture 3 3
Connection Problem 3 3
Fluid/Blood Leak 2 2
Fracture 2 2
Appropriate Term/Code Not Available 2 2
Packaging Problem 1 1
Insufficient Information 1 1
Material Frayed 1 1
False Reading From Device Non-Compliance 1 1
Disconnection 1 1
Retraction Problem 1 1
Device Alarm System 1 1
Misconnection 1 1
Unable to Obtain Readings 1 1
Delamination 1 1
Device Operates Differently Than Expected 1 1
Improper Device Output 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Improper or Incorrect Procedure or Method 1 1
Incomplete or Missing Packaging 1 1
Failure to Advance 1 1
Split 1 1
Physical Resistance 1 1
Defective Device 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 55 55
No Consequences Or Impact To Patient 52 52
No Known Impact Or Consequence To Patient 19 19
Foreign Body In Patient 7 7
Insufficient Information 4 4
Device Embedded In Tissue or Plaque 4 4
Ischemia 4 4
Hemorrhage/Bleeding 3 3
Infarction, Cerebral 2 2
No Information 2 2
No Patient Involvement 2 2
Vascular Dissection 2 2
Hematoma 1 1
Air Embolism 1 1
Occlusion 1 1
Thrombosis 1 1
Sudden Cardiac Death 1 1

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