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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 6

Device Problems
Patient-device incompatibility 13
Malposition of device 9
Human-Device Interface Issue 8
No Known Device Problem 7
Device handling issue 6
Positioning Issue 5
Difficult to deploy 4
Fracture 4
No code available 4
Device operates differently than expected 3
Kinked 3
Entrapment of device or device component 3
Improper or incorrect procedure or method 3
Device Issue 2
Pumping stopped 2
Difficult to remove 2
Crack 2
Buckled material 2
Incompatibility problem 2
Material deformation 2
Break 2
Material separation 2
Device-device incompatibility 2
Difficult to advance 1
Size incorrect for patient 1
Device stops intermittently 1
Device inoperable 1
Use of Device Issue 1
Difficult to position 1
Material frayed 1
Coiled 1
Detachment of device component 1
Bent 1
Loss of or failure to bond 1
Fluid leak 1
Difficult to fold or unfold 1
Material integrity issue 1
Torn material 1
Unintended movement 1
Deployment issue 1
Retraction problem 1
Physical resistance 1
Total Device Problems 111

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