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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device slide stainer, automated
Product CodeKPA
Regulation Number 864.3800
Device Class 1

MDR Year MDR Reports MDR Events
2019 26 26
2020 436 436
2021 323 323
2022 161 161
2023 125 125
2024 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 458 458
Mechanical Problem 321 321
Fluid/Blood Leak 249 249
Activation, Positioning or Separation Problem 87 87
Therapeutic or Diagnostic Output Failure 86 86
Leak/Splash 61 61
Break 44 44
Air/Gas in Device 19 19
Appropriate Term/Code Not Available 17 17
Fire 12 12
Circuit Failure 9 9
Output Problem 9 9
Defective Device 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Gas/Air Leak 8 8
Smoking 8 8
Thermal Decomposition of Device 7 7
False Negative Result 7 7
Use of Device Problem 6 6
Sparking 6 6
Electrical Shorting 5 5
Off-Label Use 5 5
Detachment of Device or Device Component 4 4
Loose or Intermittent Connection 4 4
Device Emits Odor 4 4
Material Discolored 4 4
Crack 3 3
Electrical /Electronic Property Problem 3 3
Device Ingredient or Reagent Problem 3 3
Device Sensing Problem 3 3
Temperature Problem 3 3
Insufficient Information 3 3
Unexpected Color 3 3
Intermittent Program or Algorithm Execution 2 2
Communication or Transmission Problem 2 2
Obstruction of Flow 2 2
Device Alarm System 2 2
Complete Blockage 2 2
Melted 2 2
Fracture 2 2
Improper or Incorrect Procedure or Method 2 2
Suction Problem 1 1
Defective Component 1 1
Component Missing 1 1
Failure to Deliver 1 1
Inaccurate Delivery 1 1
Insufficient Heating 1 1
Misconnection 1 1
Overheating of Device 1 1
Loss of Power 1 1
Intermittent Continuity 1 1
Corroded 1 1
Alarm Not Visible 1 1
False Positive Result 1 1
Degraded 1 1
Display or Visual Feedback Problem 1 1
Failure to Align 1 1
Device Displays Incorrect Message 1 1
Failure to Pump 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Unable to Obtain Readings 1 1
Device Contamination with Chemical or Other Material 1 1
Contamination /Decontamination Problem 1 1
Power Problem 1 1
Protective Measures Problem 1 1
Infusion or Flow Problem 1 1
Lack of Maintenance Documentation or Guidelines 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Mechanics Altered 1 1
No Apparent Adverse Event 1 1
Patient Data Problem 1 1
Unintended Electrical Shock 1 1
Intermittent Energy Output 1 1
Program or Algorithm Execution Failure 1 1
Suction Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 699 699
No Known Impact Or Consequence To Patient 325 325
No Consequences Or Impact To Patient 26 26
Insufficient Information 26 26
Fall 10 10
Injury 5 5
Bruise/Contusion 2 2
Pain 2 2
Unspecified Tissue Injury 2 2
Swelling/ Edema 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Discomfort 1 1
Limb Fracture 1 1
Respiratory Distress 1 1
Swelling 1 1
Burn(s) 1 1
Head Injury 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1
Laceration(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biocare Medical, LLC II Apr-01-2021
2 Dako Denmark A/S II May-21-2020
3 Hardy Diagnostics II Jun-09-2021
4 Roche Diagnostics Operations, Inc. II Oct-08-2020
5 Ventana Medical Systems Inc II Jul-12-2022
6 Ventana Medical Systems Inc II Apr-08-2022
7 Ventana Medical Systems Inc II Jun-05-2020
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