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TPLC
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Device
system and accessories, isolated heart, transport and preservation
Product Code
MSB
Regulation Number
876.5880
Device Class
2
Premarket Reviews
Manufacturer
Decision
PARAGONIX TECHNOLOGIES
SUBSTANTIALLY EQUIVALENT
1
1. K123326
SHERPA PAK CARDIAC TRANSPORT SYSTEM
2. K133432
SHERPA PAK CARDIAC TRANSPORT SYSTEM
3. K180194
SherpaPak Cardiac Transport System and SherpaPak K
...
PARAGONIX TECHNOLOGIES, INC.
SUBSTANTIALLY EQUIVALENT - KIT
1
SUBSTANTIALLY EQUIVALENT
3
1. K123326
SHERPA PAK CARDIAC TRANSPORT SYSTEM
2. K133432
SHERPA PAK CARDIAC TRANSPORT SYSTEM
3. K180194
SherpaPak Cardiac Transport System and SherpaPak K
...
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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