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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device apparatus, hemoperfusion, sorbent
Regulation Description Sorbent hemoperfusion system.
Product CodeFLD
Regulation Number 876.5870
Device Class 2

MDR Year MDR Reports MDR Events
2017 21 21
2018 9 9
2019 6 6
2020 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 23 23
Disconnection 20 20
Connector 7 7
Device Contamination with Chemical or Other Material 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Leak/Splash 3 3
Tube 2 2
Filter 1 1
Use of Device Problem 1 1
Misassembled 1 1
Fitting Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 19 19
No Consequences Or Impact To Patient 12 12
Blood Loss 4 4
No Known Impact Or Consequence To Patient 3 3
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Jan-24-2018
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