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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, dialysate delivery, semi-automatic, peritoneal
Product CodeKPF
Regulation Number 876.5630
Device Class 2

MDR Year MDR Reports MDR Events
2014 5 5
2015 1 1
2018 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4 4
Microbial Contamination of Device 1 1
Device Displays Incorrect Message 1 1
Moisture or Humidity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Peritonitis 4 4
No Known Impact Or Consequence To Patient 1 1
Diarrhea 1 1
Purulent Discharge 1 1
Unspecified Infection 1 1
Vomiting 1 1
Hernia 1 1

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