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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
2
INARI MEDICAL
SUBSTANTIALLY EQUIVALENT
1
1. K221483
FlowSaver Blood Return System
2. K231782
FlowSaver Blood Return System (80-101)
INARI MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
2
1. K221483
FlowSaver Blood Return System
2. K231782
FlowSaver Blood Return System (80-101)
MEDTRONIC PERFUSION SYSTEMS
SUBSTANTIALLY EQUIVALENT
1
PROCELL SURGICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
SISU GLOBAL HEALTH
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
88
88
2018
87
87
2019
64
64
2020
108
108
2021
73
73
2022
65
65
2023
39
39
2024
14
14
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
81
81
Crack
80
80
Material Integrity Problem
29
29
Adverse Event Without Identified Device or Use Problem
24
24
Infusion or Flow Problem
24
24
Insufficient Information
22
22
Leak/Splash
22
22
Mechanical Problem
19
19
Suction Problem
18
18
Nonstandard Device
15
15
Break
15
15
Device Misassembled During Manufacturing /Shipping
15
15
Deformation Due to Compressive Stress
13
13
Obstruction of Flow
12
12
Gas/Air Leak
12
12
Material Deformation
11
11
Improper or Incorrect Procedure or Method
11
11
Air Leak
9
9
Material Puncture/Hole
8
8
Defective Component
8
8
Device Operates Differently Than Expected
8
8
Difficult to Remove
7
7
Component Missing
6
6
Thermal Decomposition of Device
6
6
Disconnection
6
6
Electrical /Electronic Property Problem
6
6
Connection Problem
6
6
Appropriate Term/Code Not Available
6
6
Noise, Audible
6
6
No Apparent Adverse Event
5
5
Detachment of Device or Device Component
5
5
Device Alarm System
5
5
Coagulation in Device or Device Ingredient
5
5
Tear, Rip or Hole in Device Packaging
5
5
Contamination /Decontamination Problem
5
5
Device Displays Incorrect Message
4
4
Overfill
4
4
Use of Device Problem
4
4
Detachment Of Device Component
4
4
Unsealed Device Packaging
4
4
Loose or Intermittent Connection
4
4
Material Twisted/Bent
4
4
Manufacturing, Packaging or Shipping Problem
3
3
Difficult to Open or Close
3
3
Device Contamination with Chemical or Other Material
3
3
Therapeutic or Diagnostic Output Failure
3
3
Physical Resistance/Sticking
3
3
Excess Flow or Over-Infusion
3
3
Material Discolored
3
3
Vibration
3
3
Kinked
3
3
Smoking
3
3
Biocompatibility
3
3
Defective Device
3
3
Inadequate Filtration Process
2
2
Self-Activation or Keying
2
2
Device Inoperable
2
2
Insufficient Flow or Under Infusion
2
2
Fire
2
2
Burst Container or Vessel
2
2
Delivered as Unsterile Product
2
2
Occlusion Within Device
2
2
Optical Problem
2
2
Output Problem
1
1
Positioning Problem
1
1
Pressure Problem
1
1
Protective Measures Problem
1
1
Sediment, Precipitate Or Deposit In Device Or Device Ingredient
1
1
Temperature Problem
1
1
Material Split, Cut or Torn
1
1
Sharp Edges
1
1
Device Fell
1
1
Application Program Freezes, Becomes Nonfunctional
1
1
Unclear Information
1
1
Device Markings/Labelling Problem
1
1
Device Packaging Compromised
1
1
Mechanics Altered
1
1
No Flow
1
1
No Pressure
1
1
Device Emits Odor
1
1
Overheating of Device
1
1
Off-Label Use
1
1
Product Quality Problem
1
1
Reflux within Device
1
1
Inadequate Instructions for Healthcare Professional
1
1
Incorrect Measurement
1
1
Migration or Expulsion of Device
1
1
Misconnection
1
1
Moisture Damage
1
1
Partial Blockage
1
1
Contamination
1
1
Decrease in Suction
1
1
Disassembly
1
1
Fracture
1
1
Hole In Material
1
1
Entrapment of Device
1
1
Filling Problem
1
1
Invalid Sensing
1
1
Microbial Contamination of Device
1
1
Volume Accuracy Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
155
155
No Known Impact Or Consequence To Patient
104
104
No Consequences Or Impact To Patient
71
71
No Patient Involvement
47
47
No Information
33
33
Hemorrhage/Bleeding
26
26
Blood Loss
20
20
Insufficient Information
14
14
Pneumothorax
13
13
Death
13
13
Unspecified Blood or Lymphatic problem
12
12
Device Embedded In Tissue or Plaque
7
7
Cardiac Arrest
6
6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
No Code Available
4
4
Hypovolemia
4
4
Therapeutic Response, Decreased
3
3
Hemolysis
3
3
Not Applicable
3
3
Foreign Body In Patient
3
3
Low Oxygen Saturation
2
2
Respiratory Distress
2
2
Sepsis
2
2
Dyspnea
2
2
Pulmonary Embolism
2
2
Pleural Effusion
2
2
Low Blood Pressure/ Hypotension
2
2
Hypoxia
1
1
Unspecified Infection
1
1
Inflammation
1
1
Pain
1
1
Pneumonia
1
1
Hemothorax
1
1
Abscess
1
1
Adult Respiratory Distress Syndrome
1
1
Air Embolism
1
1
Bradycardia
1
1
Disseminated Intravascular Coagulation (DIC)
1
1
Thrombus
1
1
Transient Ischemic Attack
1
1
Injury
1
1
Impaired Healing
1
1
Reaction
1
1
Sudden Cardiac Death
1
1
Skin Tears
1
1
Cognitive Changes
1
1
Local Reaction
1
1
Ruptured Aneurysm
1
1
Thrombosis/Thrombus
1
1
Aspiration Pneumonitis
1
1
Cough
1
1
Blister
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
Atrium Medical Corporation
II
Feb-15-2017
5
Fenwal Inc
II
Apr-23-2019
6
Fenwal Inc
II
Mar-26-2019
7
Haemonetics Corporation
II
Jan-29-2020
8
Haemonetics Corporation
II
Jan-28-2019
9
Haemonetics Corporation
II
Aug-30-2018
10
Maquet Cardiovascular, LLC
I
Jan-12-2024
11
Medtronic Perfusion Systems
II
Jan-29-2019
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