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TPLC
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Device
pump, blood, cardiopulmonary bypass, non-roller type
Regulation Description
Nonroller-type blood pump.
Product Code
KFM
Regulation Number
870.4360
Device Class
2
Premarket Reviews
Manufacturer
Decision
CARDIACASSIST, INC.
SUBSTANTIALLY EQUIVALENT
1
INTERNATIONAL BIOPHYSICS CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC, INC.
SUBSTANTIALLY EQUIVALENT
1
QURA S.R.L
SUBSTANTIALLY EQUIVALENT
1
QURA S.R.L.
SUBSTANTIALLY EQUIVALENT
4
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
438
438
2021
446
446
2022
294
294
2023
350
350
2024
309
309
2025
33
33
Device Problems
MDRs with this Device Problem
Events in those MDRs
Electrical /Electronic Property Problem
434
434
Insufficient Information
233
233
Pumping Stopped
174
174
Adverse Event Without Identified Device or Use Problem
149
149
Noise, Audible
128
128
Infusion or Flow Problem
123
123
Mechanical Problem
113
113
Device Displays Incorrect Message
107
107
Battery Problem
77
77
Unexpected Shutdown
76
76
Overheating of Device
64
64
Inaccurate Flow Rate
46
46
Pumping Problem
35
35
Communication or Transmission Problem
27
27
Fluid/Blood Leak
22
22
Insufficient Flow or Under Infusion
18
18
No Apparent Adverse Event
18
18
Increased Pump Speed
18
18
Device Difficult to Setup or Prepare
17
17
Decreased Pump Speed
17
17
No Flow
17
17
Excessive Heating
12
12
Break
12
12
Obstruction of Flow
12
12
Leak/Splash
11
11
Display or Visual Feedback Problem
11
11
Detachment of Device or Device Component
10
10
No Display/Image
10
10
Material Twisted/Bent
9
9
Premature Discharge of Battery
8
8
Failure to Power Up
8
8
Crack
8
8
Failure to Pump
8
8
Use of Device Problem
8
8
Product Quality Problem
7
7
Electrical Power Problem
7
7
Material Deformation
7
7
Improper Flow or Infusion
7
7
Fracture
6
6
Loose or Intermittent Connection
6
6
Unexpected Therapeutic Results
6
6
Disconnection
6
6
Gas/Air Leak
5
5
Material Puncture/Hole
5
5
Image Display Error/Artifact
4
4
Device Alarm System
4
4
Fitting Problem
4
4
Labelling, Instructions for Use or Training Problem
4
4
Pressure Problem
4
4
Device Sensing Problem
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1186
1186
No Consequences Or Impact To Patient
190
190
No Patient Involvement
140
140
Insufficient Information
105
105
No Known Impact Or Consequence To Patient
81
81
Hemorrhage/Bleeding
65
65
Thrombosis/Thrombus
45
45
Hemolysis
30
30
Cardiac Arrest
28
28
Heart Failure/Congestive Heart Failure
28
28
Death
24
24
Bacterial Infection
20
20
Low Oxygen Saturation
19
19
Arrhythmia
16
16
Multiple Organ Failure
16
16
No Information
16
16
Renal Failure
15
15
Ischemia Stroke
14
14
Thromboembolism
14
14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
12
12
Sepsis
11
11
Hypoxia
11
11
Unspecified Infection
10
10
Respiratory Failure
10
10
Tachycardia
10
10
Stroke/CVA
10
10
Cardiogenic Shock
9
9
Low Blood Pressure/ Hypotension
9
9
Atrial Fibrillation
9
9
Renal Impairment
8
8
Blood Loss
8
8
Fungal Infection
7
7
Thrombus
7
7
Gastrointestinal Hemorrhage
5
5
Hemorrhagic Stroke
5
5
Intracranial Hemorrhage
5
5
Anemia
5
5
Hematoma
5
5
Ventricular Fibrillation
4
4
Bradycardia
4
4
Air Embolism
4
4
Respiratory Insufficiency
4
4
Lactate Dehydrogenase Increased
4
4
Brain Injury
4
4
Ischemia
4
4
Septic Shock
3
3
Encephalopathy
3
3
Obstruction/Occlusion
3
3
Hematuria
3
3
Hypovolemia
3
3
Recalls
Manufacturer
Recall Class
Date Posted
1
Cardiac Assist, Inc
II
Aug-25-2023
2
Cardiac Assist, Inc
II
May-11-2020
3
Maquet Cardiovascular Us Sales, Llc
III
Sep-12-2020
4
Maquet Medical Systems USA
II
Feb-02-2024
5
OriGen Biomedical, Inc.
II
Oct-30-2020
6
QURA S.R.L.
II
Aug-12-2021
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