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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device flowmeter, tube, thorpe, back-pressure compensated
Regulation Description Compensated thorpe tube flowmeter.
Product CodeCAX
Regulation Number 868.2340
Device Class 1

MDR Year MDR Reports MDR Events
2014 1 1
2015 2 2
2017 4 4
2018 3 3
2019 6 6
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Peeled/Delaminated 4 4
Crack 4 4
Flowmeter 3 3
Air Leak 1 1
Break 1 1
Burst Container or Vessel 1 1
Use of Incorrect Control Settings 1 1
Material Fragmentation 1 1
Excess Flow or Over-Infusion 1 1
Inadequate Instructions for Healthcare Professional 1 1
Material Separation 1 1
Detachment of Device or Device Component 1 1
Device Operates Differently Than Expected 1 1
Inadequate User Interface 1 1
Infusion or Flow Problem 1 1
Material Twisted/Bent 1 1
Appropriate Term/Code Not Available 1 1
Device Inoperable 1 1
Improper or Incorrect Procedure or Method 1 1
Defective Component 1 1
Detachment Of Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 8 8
Low Oxygen Saturation 3 3
Death 3 3
No Consequences Or Impact To Patient 2 2
Cardiopulmonary Arrest 1 1
No Information 1 1

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