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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device temporary non-roller type cardiac support blood pump
Definition A blood pump that provides temporary full or partial cardiac/ventricular support as an adjunctive therapy for patients considered high risk for cardiac procedures
Product CodeOZD
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
0 0 0 0 0 0 0 0 5 8 2

Device Problems
No Known Device Problem 5
Malposition of device 4
Patient-device incompatibility 3
Difficult to deploy 3
Device operates differently than expected 3
Human-Device Interface Issue 2
Fracture 2
Buckled material 2
Kinked 2
Positioning Issue 2
Unintended movement 1
Device handling issue 1
Difficult to remove 1
Material separation 1
Improper or incorrect procedure or method 1
Device Issue 1
Physical resistance 1
Loss of or failure to bond 1
Break 1
Coiled 1
Detachment of device component 1
Material frayed 1
Material integrity issue 1
Device-device incompatibility 1
Difficult to advance 1
Total Device Problems 43

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