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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device container, i.v.
Product CodeKPE
Regulation Number 880.5025
Device Class 2


Premarket Reviews
ManufacturerDecision
BEIJING L&Z MEDICAL TECHNOLOGY DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EPIC MEDICAL PTE LTD
  SUBSTANTIALLY EQUIVALENT 1
GILERO, LLC
  SUBSTANTIALLY EQUIVALENT 1
HAEMOTRONIC S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
HAEMOTRONIC, SPA
  SUBSTANTIALLY EQUIVALENT 1
HEALTH CARE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL MEDICAL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
VALMED SRL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 142 157
2019 204 256
2020 147 147
2021 161 161
2022 112 112
2023 95 95

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 276 314
Device Contamination with Chemical or Other Material 246 274
Contamination /Decontamination Problem 153 153
Break 41 41
Leak/Splash 35 35
Disconnection 32 32
Detachment of Device or Device Component 18 18
Material Puncture/Hole 14 14
Particulates 10 10
Contamination 10 10
Crack 9 9
Degraded 9 9
Material Split, Cut or Torn 8 8
Material Rupture 7 7
Difficult to Open or Close 6 6
Device Dislodged or Dislocated 6 6
Material Separation 5 5
Mechanical Problem 5 5
Defective Component 4 4
Component Missing 4 4
Contamination of Device Ingredient or Reagent 4 4
Component Misassembled 4 4
Failure to Disconnect 3 4
Defective Device 3 3
No Flow 3 3
Tear, Rip or Hole in Device Packaging 3 3
Cut In Material 3 3
Material Perforation 3 3
Loose or Intermittent Connection 3 3
Fracture 3 3
Hole In Material 2 2
Microbial Contamination of Device 2 2
Device Slipped 2 2
Product Quality Problem 2 2
Device Difficult to Setup or Prepare 2 2
Decrease in Pressure 2 2
Improper Flow or Infusion 2 2
Unexpected Color 2 2
Device Fell 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Integrity Problem 2 2
Scratched Material 2 2
Material Deformation 1 1
Priming Problem 1 1
Separation Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Free or Unrestricted Flow 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Pressure Problem 1 1
Pumping Problem 1 1
Application Program Problem 1 1
Fail-Safe Problem 1 1
Device Markings/Labelling Problem 1 1
Precipitate in Device or Device Ingredient 1 1
Premature Activation 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Device Damaged Prior to Use 1 1
Failure to Advance 1 1
Obstruction of Flow 1 1
Labelling, Instructions for Use or Training Problem 1 1
Burst Container or Vessel 1 1
Entrapment of Device 1 1
Filling Problem 1 1
Misassembled 1 1
Misconnection 1 1
Delivered as Unsterile Product 1 1
Unsealed Device Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 380 434
No Clinical Signs, Symptoms or Conditions 349 349
No Consequences Or Impact To Patient 48 56
No Known Impact Or Consequence To Patient 43 48
Insufficient Information 30 30
No Information 9 9
Air Embolism 2 2
Hypoxia 2 2
Sprain 1 1
Exposure to Body Fluids 1 1
Chemical Exposure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Nov-02-2018
2 Baxter Healthcare Corporation II Jan-11-2018
3 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
4 Stradis Healthcare II Jan-11-2023
5 The Metrix Company II Oct-01-2019
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