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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
2
HAEMONETICS CORPORATION
SUBSTANTIALLY EQUIVALENT
1
INARI MEDICAL
SUBSTANTIALLY EQUIVALENT
1
INARI MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
2
INQUIS MEDICAL
SUBSTANTIALLY EQUIVALENT
1
PROCELL SURGICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
SISU GLOBAL HEALTH
SUBSTANTIALLY EQUIVALENT
1
SORIN GROUP ITALIA S.R.L.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2019
64
64
2020
108
108
2021
73
73
2022
65
65
2023
39
39
2024
90
104
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
96
96
Crack
80
80
Mechanical Problem
36
36
Material Integrity Problem
29
29
Insufficient Information
19
19
Adverse Event Without Identified Device or Use Problem
17
17
Obstruction of Flow
16
16
Device Misassembled During Manufacturing /Shipping
15
15
Nonstandard Device
15
15
Material Deformation
14
14
Deformation Due to Compressive Stress
13
13
Leak/Splash
12
12
Optical Problem
12
12
Electrical /Electronic Property Problem
12
12
Noise, Audible
10
10
Gas/Air Leak
8
8
Device Alarm System
8
8
Material Puncture/Hole
8
8
Appropriate Term/Code Not Available
8
8
Suction Problem
6
6
Infusion or Flow Problem
5
5
No Apparent Adverse Event
5
5
Contamination /Decontamination Problem
5
5
Break
4
4
Improper or Incorrect Procedure or Method
4
4
Material Twisted/Bent
4
4
Delivered as Unsterile Product
3
3
Component Missing
3
3
Material Discolored
3
3
Air/Gas in Device
3
3
Therapeutic or Diagnostic Output Failure
3
3
Defective Device
3
3
Smoking
3
3
Connection Problem
3
3
Physical Resistance/Sticking
3
3
Disconnection
3
3
Contamination
2
2
Fracture
2
2
Defective Component
2
2
Use of Device Problem
2
2
Self-Activation or Keying
2
2
Loose or Intermittent Connection
2
2
Thermal Decomposition of Device
2
2
Detachment of Device or Device Component
2
16
Burst Container or Vessel
2
2
Application Program Freezes, Becomes Nonfunctional
1
1
Protective Measures Problem
1
1
Free or Unrestricted Flow
1
1
Overheating of Device
1
1
Device Contamination with Chemical or Other Material
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
209
223
No Known Impact Or Consequence To Patient
60
60
Hemorrhage/Bleeding
51
51
No Patient Involvement
31
31
No Consequences Or Impact To Patient
29
29
Insufficient Information
15
15
Unspecified Blood or Lymphatic problem
12
12
No Information
8
8
Death
8
8
Blood Loss
7
7
Hypovolemia
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
Cardiac Arrest
3
3
Hemolysis
3
3
Pneumothorax
3
3
Respiratory Distress
2
2
Low Blood Pressure/ Hypotension
2
2
Pleural Effusion
2
2
Low Cardiac Output
2
2
Foreign Body In Patient
2
2
Thrombosis/Thrombus
2
2
Unspecified Heart Problem
1
1
Aspiration Pneumonitis
1
1
Cough
1
1
Blister
1
1
No Code Available
1
1
Sudden Cardiac Death
1
1
Skin Tears
1
1
Cognitive Changes
1
1
Low Oxygen Saturation
1
1
Unspecified Infection
1
1
Hemothorax
1
1
Thrombus
1
1
Local Reaction
1
1
Renal Failure
1
1
Dyspnea
1
1
Pulmonary Embolism
1
1
Air Embolism
1
1
Bacterial Infection
1
1
Bradycardia
1
1
Ruptured Aneurysm
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Atrium Medical Corporation
II
Dec-28-2023
2
Atrium Medical Corporation
II
Dec-02-2023
3
Atrium Medical Corporation
II
Nov-16-2023
4
Fenwal Inc
II
Apr-23-2019
5
Fenwal Inc
II
Mar-26-2019
6
Haemonetics Corporation
II
Jan-29-2020
7
Haemonetics Corporation
II
Jan-28-2019
8
Maquet Cardiovascular, LLC
I
Jan-12-2024
9
Medtronic Perfusion Systems
II
Jan-29-2019
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