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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device detector, bubble, cardiopulmonary bypass
Product CodeKRL
Regulation Number 870.4205
Device Class 2


Premarket Reviews
ManufacturerDecision
SORIN GROUP DEUTSCHLAND GMBH
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2015 6 6
2016 18 18
2017 11 11
2018 2 2
2019 4 4
2022 20 20
2023 17 17
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Low Readings 21 21
Device Sensing Problem 14 14
False Alarm 11 11
Break 7 7
Over-Sensing 5 5
Device Operational Issue 5 5
Detachment Of Device Component 4 4
Pumping Stopped 3 3
Under-Sensing 3 3
Device Alarm System 2 2
Failure to Sense 2 2
Device Displays Incorrect Message 2 2
Deflation Problem 2 2
Unexpected Shutdown 2 2
Material Integrity Problem 2 2
Physical Property Issue 1 1
Appropriate Term/Code Not Available 1 1
Difficult to Open or Close 1 1
Disconnection 1 1
Fracture 1 1
Failure to Reset 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Sensing Intermittently 1 1
Deformation Due to Compressive Stress 1 1
Communication or Transmission Problem 1 1
Connection Problem 1 1
Device Operates Differently Than Expected 1 1
Other (for use when an appropriate device code cannot be identified) 1 1
Device Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 39 39
No Consequences Or Impact To Patient 25 25
No Patient Involvement 14 14
No Known Impact Or Consequence To Patient 2 2
No Information 1 1
Air Embolism 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Terumo Cardiovascular Systems Corporation II Oct-08-2010
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