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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, warming. blood and plasma
Product CodeKZL
Regulation Number 864.9205
Device Class 2


Premarket Reviews
ManufacturerDecision
BARKEY GMBH & CO KG
  SUBSTANTIALLY EQUIVALENT 1
BELMONT INSTRUMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BOEKEL SCIENTIFIC, INC
  SUBSTANTIALLY EQUIVALENT 1
FREMON SCIENTIFIC INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 25 25
2015 16 16
2016 10 10
2017 5 5
2018 3 3
2019 2 2
2020 53 53
2021 71 71
2022 102 102
2023 106 106
2024 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 156 156
Leak/Splash 83 83
Deformation Due to Compressive Stress 23 23
Scratched Material 19 19
Break 17 17
Infusion or Flow Problem 15 15
Connection Problem 15 15
Material Rupture 11 11
Component Missing 9 9
Obstruction of Flow 9 9
Temperature Problem 8 8
Improper Flow or Infusion 8 8
Device Damaged Prior to Use 7 7
Device Operates Differently Than Expected 6 6
Crack 6 6
Material Separation 5 5
Device Contamination with Chemical or Other Material 5 5
Detachment of Device or Device Component 5 5
Defective Component 5 5
Fitting Problem 5 5
Pressure Problem 3 3
No Pressure 3 3
Melted 3 3
Air Leak 3 3
Fracture 3 3
Disconnection 3 3
Material Split, Cut or Torn 3 3
Audible Prompt/Feedback Problem 2 2
Priming Problem 2 2
Separation Problem 2 2
Electrical /Electronic Property Problem 2 2
Device Alarm System 2 2
Partial Blockage 2 2
Detachment Of Device Component 2 2
Misassembled 2 2
Loose or Intermittent Connection 2 2
Mechanical Problem 2 2
Kinked 2 2
Insufficient Flow or Under Infusion 2 2
Material Deformation 2 2
Positioning Problem 2 2
Defective Device 2 2
Structural Problem 2 2
Free or Unrestricted Flow 2 2
Improper Device Output 2 2
Failure of Device to Self-Test 2 2
Device Misassembled During Manufacturing /Shipping 1 1
Failure to Align 1 1
Physical Resistance 1 1
Pumping Problem 1 1
Insufficient Information 1 1
Component Misassembled 1 1
Material Integrity Problem 1 1
Material Protrusion/Extrusion 1 1
Material Twisted/Bent 1 1
No Flow 1 1
Output Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Inoperable 1 1
Out-Of-Box Failure 1 1
Failure to Infuse 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Sense 1 1
Output above Specifications 1 1
Overheating of Device 1 1
Device Difficult to Setup or Prepare 1 1
Failure to Prime 1 1
Product Quality Problem 1 1
Contamination 1 1
Deflation Problem 1 1
Loss of or Failure to Bond 1 1
Unintended Ejection 1 1
Restricted Flow rate 1 1
Inaccurate Flow Rate 1 1
Grounding Malfunction 1 1
Insufficient Heating 1 1
Incomplete or Inadequate Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 257 257
No Consequences Or Impact To Patient 40 40
No Known Impact Or Consequence To Patient 31 31
Insufficient Information 25 25
No Patient Involvement 23 23
No Information 11 11
Death 8 8
Low Blood Pressure/ Hypotension 3 3
Hypothermia 3 3
No Code Available 3 3
Patient Problem/Medical Problem 1 1
Hemolytic Anemia 1 1
Complaint, Ill-Defined 1 1
Therapy/non-surgical treatment/delayed/prolonged 1 1
Abdominal Distention 1 1
Hypovolemic Shock 1 1
Paralysis 1 1
Exsanguination 1 1
Hemorrhage/Bleeding 1 1
Pulmonary Embolism 1 1
Air Embolism 1 1
Exposure to Body Fluids 1 1

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