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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device autonomous extracorporeal blood leak detector/alarm
Definition To detect the presence of blood leaking from an extracorporeal connection or needle site in hemodialysis patients and alert the user or attending staff. The device detects colormetric, chemical, or light modulation caused by exposure to leaking blood.
Product CodeODX
Regulation Number 876.5820
Device Class 2

MDR Year MDR Reports MDR Events
2020 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hemorrhage/Bleeding 1 1
No Known Impact Or Consequence To Patient 1 1

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