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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system and accessories, isolated heart, transport and preservation
Product CodeMSB
Regulation Number 876.5880
Device Class 2


Premarket Reviews
ManufacturerDecision
PARAGONIX TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
PARAGONIX TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 3
S.A.L.F. SPA
  SUBSTANTIALLY EQUIVALENT 1
TRANSMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 18 18
2015 1 1
2018 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 7 7
Device Operates Differently Than Expected 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Appropriate Term/Code Not Available 2 2
Product Quality Problem 2 2
Patient-Device Incompatibility 2 2
Fluid/Blood Leak 1 1
Microbial Contamination of Device 1 1
Incorrect Or Inadequate Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Death 11 11
Coagulation Disorder 6 6
Failure of Implant 6 6
Renal Failure 4 4
Bacterial Infection 3 3
Pneumonia 3 3
No Known Impact Or Consequence To Patient 3 3
Respiratory Failure 3 3
Fungal Infection 2 2
Depression 2 2
Weakness 2 2
Heart Failure 2 2
Pulmonary Embolism 2 2
Hypoxia 2 2
Respiratory Distress 2 2
Right Ventricular Dysfunction 1 1
Thrombosis 1 1
Thyroid Problems 1 1
Ischemia 1 1
Muscle Weakness 1 1
Myocardial Infarction 1 1
Neurological Deficit/Dysfunction 1 1
Neuropathy 1 1
Pain 1 1
Hemorrhage/Bleeding 1 1
Low Blood Pressure/ Hypotension 1 1
Arrhythmia 1 1
Cardiopulmonary Arrest 1 1
Therapeutic Response, Decreased 1 1
Complaint, Ill-Defined 1 1
Reaction 1 1
Low Cardiac Output 1 1
Weight Changes 1 1
Test Result 1 1
No Information 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Vitrolife, Inc. II Jul-12-2011
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