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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device fluorometer, for clinical use
Regulation Description Fluorometer for clinical use.
Product CodeKHO
Regulation Number 862.2560
Device Class 1

MDR Year MDR Reports MDR Events
2020 257 257
2021 213 213
2022 224 224
2023 260 260
2024 168 168
2025 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 603 603
Incorrect, Inadequate or Imprecise Result or Readings 174 174
Electrical /Electronic Property Problem 44 44
Failure to Align 40 40
Obstruction of Flow 29 29
High Readings 24 24
High Test Results 21 21
Fluid/Blood Leak 15 15
Infusion or Flow Problem 14 14
Noise, Audible 13 13
Leak/Splash 12 12
Mechanical Jam 12 12
Loose or Intermittent Connection 11 11
Display or Visual Feedback Problem 11 11
Temperature Problem 9 9
Low Readings 8 8
Output Problem 8 8
Material Twisted/Bent 8 8
Low Test Results 8 8
Non Reproducible Results 7 7
Suction Failure 6 6
Failure to Pump 6 6
Computer Software Problem 6 6
Decreased Sensitivity 6 6
No Flow 5 5
Priming Problem 5 5
Suction Problem 5 5
Intermittent Continuity 5 5
Electrical Power Problem 5 5
Air/Gas in Device 4 4
Break 4 4
Image Display Error/Artifact 4 4
Use of Device Problem 3 3
Communication or Transmission Problem 3 3
Detachment of Device or Device Component 3 3
Material Deformation 3 3
Complete Blockage 3 3
Electrical Shorting 3 3
Patient Data Problem 3 3
Data Problem 3 3
Display Difficult to Read 3 3
Pressure Problem 3 3
Intermittent Communication Failure 2 2
Loss of Power 2 2
Failure to Deliver 2 2
Device Sensing Problem 2 2
Disconnection 2 2
Partial Blockage 2 2
Degraded 2 2
Device Ingredient or Reagent Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 936 936
No Known Impact Or Consequence To Patient 187 187
Insufficient Information 10 10
Missing Value Reason 1 1
Electric Shock 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Tosoh Bioscience Inc II Jun-23-2020
2 Tosoh Bioscience Inc II Feb-11-2020
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