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TPLC
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Device
apparatus, autotransfusion
Product Code
CAC
Regulation Number
868.5830
Device Class
2
Premarket Reviews
Manufacturer
Decision
ATRIUM MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
FRESENIUS KABI AG
SUBSTANTIALLY EQUIVALENT
3
HAEMONETICS CORPORATION
SUBSTANTIALLY EQUIVALENT
1
INARI MEDICAL
SUBSTANTIALLY EQUIVALENT
1
INARI MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC PERFUSION SYSTEMS
SUBSTANTIALLY EQUIVALENT
1
PROCELL SURGICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
SISU GLOBAL HEALTH
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
87
87
2019
64
64
2020
108
108
2021
77
77
2022
70
70
2023
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Crack
76
76
Fluid/Blood Leak
67
67
Material Integrity Problem
28
28
Adverse Event Without Identified Device or Use Problem
20
20
Insufficient Information
20
20
Leak/Splash
16
16
Nonstandard Device
15
15
Device Misassembled During Manufacturing /Shipping
15
15
Deformation Due to Compressive Stress
14
14
Gas/Air Leak
12
12
Suction Problem
11
11
Infusion or Flow Problem
9
9
Break
8
8
Difficult to Remove
7
7
Appropriate Term/Code Not Available
7
7
Material Deformation
7
7
Noise, Audible
6
6
Thermal Decomposition of Device
6
6
Material Twisted/Bent
6
6
Component Missing
6
6
Obstruction of Flow
6
6
Contamination /Decontamination Problem
6
6
Defective Component
5
5
Device Operates Differently Than Expected
5
5
Coagulation in Device or Device Ingredient
5
5
Mechanical Problem
5
5
Improper or Incorrect Procedure or Method
5
5
No Apparent Adverse Event
5
5
Therapeutic or Diagnostic Output Failure
4
4
Material Puncture/Hole
4
4
Air Leak
4
4
Overfill
4
4
Defective Device
3
3
Detachment Of Device Component
3
3
Disconnection
3
3
Physical Resistance/Sticking
3
3
Excess Flow or Over-Infusion
2
2
Loose or Intermittent Connection
2
2
Device Alarm System
2
2
Burst Container or Vessel
2
2
Delivered as Unsterile Product
2
2
Occlusion Within Device
2
2
Kinked
2
2
Use of Device Problem
2
2
Self-Activation or Keying
2
2
Increase in Suction
2
2
Device Tipped Over
2
2
Device Displays Incorrect Message
2
2
Connection Problem
2
2
Detachment of Device or Device Component
2
2
Tear, Rip or Hole in Device Packaging
2
2
Inadequate Filtration Process
2
2
Insufficient Flow or Under Infusion
2
2
Difficult to Open or Close
2
2
Device Contamination with Chemical or Other Material
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Calibration Problem
1
1
Chemical Problem
1
1
Mechanics Altered
1
1
No Flow
1
1
No Pressure
1
1
Output Problem
1
1
Positioning Problem
1
1
Protective Measures Problem
1
1
Temperature Problem
1
1
Microbial Contamination of Device
1
1
Device Contamination with Body Fluid
1
1
Device Markings/Labelling Problem
1
1
Blocked Connection
1
1
Device Inoperable
1
1
Inadequacy of Device Shape and/or Size
1
1
Smoking
1
1
Vibration
1
1
Volume Accuracy Problem
1
1
Device Emits Odor
1
1
Overheating of Device
1
1
Unsealed Device Packaging
1
1
Product Quality Problem
1
1
Reflux within Device
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Contamination
1
1
Decrease in Suction
1
1
Incorrect Measurement
1
1
Migration or Expulsion of Device
1
1
Misconnection
1
1
Inadequate Instructions for Healthcare Professional
1
1
Filling Problem
1
1
Fire
1
1
Sharp Edges
1
1
Device Fell
1
1
Application Program Freezes, Becomes Nonfunctional
1
1
Unclear Information
1
1
Missing Information
1
1
Material Split, Cut or Torn
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
123
123
No Known Impact Or Consequence To Patient
83
83
No Consequences Or Impact To Patient
51
51
No Patient Involvement
38
38
No Information
23
23
Insufficient Information
14
14
Unspecified Blood or Lymphatic problem
12
12
Death
11
11
Hemorrhage/Bleeding
11
11
Pneumothorax
9
9
Blood Loss
9
9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
6
6
No Code Available
3
3
Foreign Body In Patient
3
3
Device Embedded In Tissue or Plaque
3
3
Low Oxygen Saturation
3
3
Hypovolemia
3
3
Therapeutic Response, Decreased
2
2
Respiratory Distress
2
2
Sepsis
2
2
Cardiac Arrest
2
2
Pleural Effusion
2
2
Low Blood Pressure/ Hypotension
2
2
Dyspnea
2
2
Pulmonary Embolism
2
2
Adult Respiratory Distress Syndrome
1
1
Air Embolism
1
1
Bradycardia
1
1
Hemolysis
1
1
Disseminated Intravascular Coagulation (DIC)
1
1
Hypoxia
1
1
Unspecified Infection
1
1
Inflammation
1
1
Pain
1
1
Pneumonia
1
1
Hemothorax
1
1
Local Reaction
1
1
Sudden Cardiac Death
1
1
Skin Tears
1
1
Cognitive Changes
1
1
Thrombus
1
1
Transient Ischemic Attack
1
1
Injury
1
1
Aspiration Pneumonitis
1
1
Cough
1
1
Blister
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Fenwal Inc
II
Apr-23-2019
2
Fenwal Inc
II
Mar-26-2019
3
Haemonetics Corporation
II
Jan-29-2020
4
Haemonetics Corporation
II
Jan-28-2019
5
Haemonetics Corporation
II
Aug-30-2018
6
Medtronic Perfusion Systems
II
Jan-29-2019
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