Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 45 45

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 171 171
Leak/Splash 84 84
Deformation Due to Compressive Stress 23 23
Scratched Material 19 19
Break 18 18
Connection Problem 15 15
Infusion or Flow Problem 15 15
Fitting Problem 11 11
Material Rupture 11 11
Obstruction of Flow 10 10
Component Missing 9 9
Temperature Problem 8 8
Improper Flow or Infusion 8 8
Disconnection 7 7
Crack 7 7
Device Damaged Prior to Use 7 7
Device Operates Differently Than Expected 6 6
Material Separation 6 6
Device Contamination with Chemical or Other Material 5 5
Detachment of Device or Device Component 5 5
Defective Component 5 5
Overheating of Device 4 4
Fracture 4 4
Defective Device 4 4
Pressure Problem 3 3
Material Split, Cut or Torn 3 3
Loose or Intermittent Connection 3 3
Air Leak 3 3
No Pressure 3 3
Separation Problem 3 3
Melted 3 3
Device Alarm System 3 3
Material Deformation 3 3
Improper Device Output 2 2
Detachment Of Device Component 2 2
Electrical /Electronic Property Problem 2 2
Priming Problem 2 2
Failure of Device to Self-Test 2 2
Mechanical Problem 2 2
Free or Unrestricted Flow 2 2
Partial Blockage 2 2
Kinked 2 2
Misassembled 2 2
Audible Prompt/Feedback Problem 2 2
Structural Problem 2 2
Insufficient Flow or Under Infusion 2 2
Material Twisted/Bent 2 2
Positioning Problem 2 2
Insufficient Information 1 1
Physical Resistance 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 290 290
No Consequences Or Impact To Patient 40 40
No Known Impact Or Consequence To Patient 31 31
Insufficient Information 28 28
No Patient Involvement 23 23
No Information 11 11
Death 8 8
No Code Available 3 3
Hypothermia 3 3
Low Blood Pressure/ Hypotension 3 3
Air Embolism 1 1
Hypovolemic Shock 1 1
Patient Problem/Medical Problem 1 1
Complaint, Ill-Defined 1 1
Exsanguination 1 1
Abdominal Distention 1 1
Hemolytic Anemia 1 1
Paralysis 1 1
Exposure to Body Fluids 1 1
Therapy/non-surgical treatment/delayed/prolonged 1 1
Hemorrhage/Bleeding 1 1
Pulmonary Embolism 1 1

-
-