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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device centrifuge, hematocrit
Product CodeGKG
Regulation Number 864.6400
Device Class 2

MDR Year MDR Reports MDR Events
2014 15 15
2015 3 3
2019 4 4
2020 1 1
2021 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Inoperable 12 12
Thermal Decomposition of Device 5 5
Fracture 4 4
Melted 3 3
Smoking 3 3
Device Operates Differently Than Expected 3 3
Material Fragmentation 2 2
Leak/Splash 2 2
Detachment Of Device Component 2 2
Component Falling 1 1
Charred 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1
Loss of Threshold 1 1
Device Emits Odor 1 1
Loss of Power 1 1
Improper or Incorrect Procedure or Method 1 1
Physical Resistance 1 1
Sparking 1 1
Detachment of Device or Device Component 1 1
Unintended Movement 1 1
Misassembly by Users 1 1
Noise, Audible 1 1
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 12 12
No Known Impact Or Consequence To Patient 10 10
No Clinical Signs, Symptoms or Conditions 2 2
Abrasion 1 1
Laceration(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Hettich Instruments Management I I Jan-21-2010
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