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TPLC
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Device
control, pump speed, cardiopulmonary bypass
Product Code
DWA
Regulation Number
870.4380
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT (FORMERLY THORATEC CORPORATION)
SUBSTANTIALLY EQUIVALENT
1
AMPTD INC.
SUBSTANTIALLY EQUIVALENT
1
1. K230698
Anivia SG1000 Pump Console
APMTD, INC.
SUBSTANTIALLY EQUIVALENT
1
LEVITRONIX LLC.
SUBSTANTIALLY EQUIVALENT
3
MEDTRONIC INC.
SUBSTANTIALLY EQUIVALENT
1
SORIN GROUP DEUTSCHLAND GMBH
SUBSTANTIALLY EQUIVALENT
3
SPECTRUM MEDICAL LTD
SUBSTANTIALLY EQUIVALENT
1
THORATEC CORP
SUBSTANTIALLY EQUIVALENT
1
THORATEC CORPORATION (NOW PART OF ABBOTT)
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
98
98
2015
103
103
2016
109
109
2017
140
140
2018
198
198
2019
375
375
2020
146
146
2021
155
155
2022
205
205
2023
438
438
2024
103
103
Device Problems
MDRs with this Device Problem
Events in those MDRs
Pumping Stopped
205
205
Insufficient Information
202
202
Battery Problem
155
155
Power Problem
148
148
Infusion or Flow Problem
137
137
Device Alarm System
132
132
Mechanical Problem
125
125
No Display/Image
115
115
Other (for use when an appropriate device code cannot be identified)
87
87
Pumping Problem
85
85
Noise, Audible
82
82
Electrical /Electronic Property Problem
66
66
Device Displays Incorrect Message
65
65
Decreased Pump Speed
64
64
Unexpected Shutdown
63
63
Display or Visual Feedback Problem
62
62
Communication or Transmission Problem
56
56
Overheating of Device
54
54
Device Operates Differently Than Expected
37
37
No Flow
37
37
Device Stops Intermittently
35
35
Smoking
30
30
Obstruction of Flow
27
27
Appropriate Term/Code Not Available
27
27
Failure to Power Up
25
25
Break
24
24
Device Operational Issue
24
24
Incorrect, Inadequate or Imprecise Result or Readings
23
23
Insufficient Flow or Under Infusion
19
19
Electrical Power Problem
18
18
Loss of Power
17
17
No Apparent Adverse Event
17
17
Vibration
16
16
Improper or Incorrect Procedure or Method
14
14
Adverse Event Without Identified Device or Use Problem
14
14
Inaccurate Flow Rate
13
13
Partial Blockage
13
13
Material Deformation
11
11
Detachment of Device or Device Component
10
10
Device Inoperable
10
10
Unable to Obtain Readings
9
9
Use of Device Problem
9
9
Excessive Heating
9
9
Mechanical Jam
8
8
Improper Flow or Infusion
8
8
Temperature Problem
8
8
Loose or Intermittent Connection
8
8
No Audible Alarm
8
8
Failure to Run on Battery
7
7
Output Problem
7
7
Difficult to Open or Close
7
7
Device Issue
7
7
Invalid Sensing
7
7
Connection Problem
7
7
Nonstandard Device
6
6
Increased Pump Speed
6
6
Failure to Pump
6
6
Erratic or Intermittent Display
6
6
Disconnection
5
5
Alarm Not Visible
5
5
Thermal Decomposition of Device
5
5
Failure to Charge
5
5
No Device Output
5
5
Visual Prompts will not Clear
5
5
Defective Component
5
5
Physical Property Issue
5
5
Data Problem
5
5
Failure of Device to Self-Test
4
4
Maintenance Does Not Comply To Manufacturers Recommendations
4
4
Device Sensing Problem
4
4
Fracture
4
4
Increase in Pressure
4
4
Failure to Cycle
4
4
Decoupling
4
4
Intermittent Communication Failure
4
4
Complete Loss of Power
4
4
Crack
3
3
Image Display Error/Artifact
3
3
Device Difficult to Setup or Prepare
3
3
Failure to Align
3
3
Calibration Problem
3
3
Improper Device Output
3
3
Electrical Shorting
3
3
Device Dislodged or Dislocated
2
2
Inappropriate or Unexpected Reset
2
2
Material Integrity Problem
2
2
Therapeutic or Diagnostic Output Failure
2
2
Unintended Movement
2
2
Positioning Problem
2
2
Charging Problem
2
2
Sparking
2
2
Low Battery
2
2
Defective Device
2
2
Device Markings/Labelling Problem
2
2
Excess Flow or Over-Infusion
2
2
Difficult to Insert
2
2
Misconnection
2
2
Material Puncture/Hole
2
2
Self-Activation or Keying
2
2
Failure to Sense
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
873
873
No Consequences Or Impact To Patient
463
463
No Patient Involvement
274
274
No Known Impact Or Consequence To Patient
272
272
No Patient involvement
43
43
Low Blood Pressure/ Hypotension
28
28
Insufficient Information
24
24
Low Oxygen Saturation
20
20
Death
20
20
No Information
18
18
Cardiac Arrest
17
17
Complaint, Ill-Defined
17
17
Thrombus
9
9
Dizziness
6
6
Hemolysis
6
6
No Code Available
6
6
Hemorrhage/Bleeding
5
5
Hypoxia
5
5
Bradycardia
5
5
Loss of consciousness
5
5
Anxiety
4
4
Infarction, Cerebral
4
4
Not Applicable
4
4
Blood Loss
4
4
Patient Problem/Medical Problem
3
3
Neurological Deficit/Dysfunction
3
3
Seizures
2
2
Ventilator Dependent
2
2
Cardiogenic Shock
2
2
Heart Failure
2
2
Air Embolism
2
2
Dyspnea
2
2
Respiratory Failure
2
2
Multiple Organ Failure
2
2
Asystole
2
2
Respiratory Insufficiency
2
2
Unspecified Tissue Injury
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Cardiovascular Insufficiency
1
1
Syncope/Fainting
1
1
Thrombosis/Thrombus
1
1
Hematuria
1
1
Embolus
1
1
Exsanguination
1
1
Hematoma
1
1
Ischemia
1
1
Bacterial Infection
1
1
Syncope
1
1
Chest Pain
1
1
Cardiopulmonary Arrest
1
1
Stroke/CVA
1
1
Hypovolemia
1
1
Coma
1
1
Shock
1
1
Thrombosis
1
1
Ventricular Fibrillation
1
1
Pulmonary Edema
1
1
Rash
1
1
Respiratory Distress
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cardiac Assist, Inc
I
Jan-19-2023
2
Cardiac Assist, Inc
I
Sep-23-2022
3
LivaNova Deutschland GmbH
III
Mar-15-2022
4
LivaNova Deutschland GmbH
II
Jul-08-2020
5
Medtronic Cardiovascular Revascularization & Surgical Therap
II
Jun-30-2010
6
Medtronic Perfusion Systems
I
Mar-26-2021
7
Sorin Group Deutschland GmbH
II
Jan-19-2018
8
Sorin Group Deutschland GmbH
II
Jan-28-2014
9
Sorin Group Deutschland GmbH
II
Mar-29-2012
10
Sorin Group USA, Inc.
II
Oct-29-2012
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