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TPLC
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Device
pump, blood, cardiopulmonary bypass, non-roller type
Product Code
KFM
Regulation Number
870.4360
Device Class
2
Premarket Reviews
Manufacturer
Decision
CARDIACASSIST INC
SUBSTANTIALLY EQUIVALENT
1
CARDIACASSIST, INC.
SUBSTANTIALLY EQUIVALENT
1
INTERNATIONAL BIOPHYSICS CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC INC
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC, INC.
SUBSTANTIALLY EQUIVALENT
1
QURA S.R.L
SUBSTANTIALLY EQUIVALENT
1
QURA S.R.L.
SUBSTANTIALLY EQUIVALENT
4
SORIN GROUP ITALIA S.R.L.
SUBSTANTIALLY EQUIVALENT
1
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
310
310
2020
438
438
2021
447
447
2022
294
294
2023
354
354
2024
162
162
Device Problems
MDRs with this Device Problem
Events in those MDRs
Electrical /Electronic Property Problem
353
353
Insufficient Information
231
231
Adverse Event Without Identified Device or Use Problem
188
188
Noise, Audible
177
177
Pumping Stopped
177
177
Infusion or Flow Problem
122
122
Device Displays Incorrect Message
119
119
Mechanical Problem
116
116
Overheating of Device
88
88
Battery Problem
75
75
Unexpected Shutdown
75
75
Communication or Transmission Problem
47
47
Pumping Problem
37
37
Inaccurate Flow Rate
35
35
No Flow
26
26
Decreased Pump Speed
25
25
Insufficient Flow or Under Infusion
22
22
Fluid/Blood Leak
21
21
Increased Pump Speed
20
20
No Apparent Adverse Event
18
18
No Display/Image
17
17
Break
16
16
Material Twisted/Bent
16
16
Excessive Heating
16
16
Device Difficult to Setup or Prepare
15
15
Disconnection
14
14
Display or Visual Feedback Problem
14
14
Obstruction of Flow
12
12
Electrical Power Problem
12
12
Use of Device Problem
11
11
Leak/Splash
11
11
Crack
10
10
Failure to Pump
10
10
Power Problem
10
10
Failure to Power Up
9
9
Product Quality Problem
8
8
Premature Discharge of Battery
8
8
Loose or Intermittent Connection
7
7
Vibration
7
7
Connection Problem
7
7
Detachment of Device or Device Component
7
7
Unexpected Therapeutic Results
6
6
Material Deformation
6
6
Improper Flow or Infusion
6
6
Fitting Problem
6
6
Loss of Power
6
6
Fracture
6
6
Device Alarm System
5
5
Erratic or Intermittent Display
5
5
Temperature Problem
5
5
Charging Problem
5
5
Device Sensing Problem
4
4
Gas/Air Leak
4
4
Pressure Problem
4
4
Appropriate Term/Code Not Available
4
4
Image Display Error/Artifact
4
4
Labelling, Instructions for Use or Training Problem
4
4
Material Puncture/Hole
4
4
Incorrect, Inadequate or Imprecise Result or Readings
3
3
Failure to Read Input Signal
3
3
Defective Component
3
3
Failure to Deliver
3
3
Inaccurate Delivery
3
3
Decoupling
3
3
Backflow
3
3
Physical Resistance/Sticking
3
3
No Visual Prompts/Feedback
3
3
Protective Measures Problem
3
3
Misassembly by Users
3
3
Therapeutic or Diagnostic Output Failure
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Electrical Shorting
3
3
Failure to Shut Off
2
2
Filtration Problem
2
2
Contamination /Decontamination Problem
2
2
Material Integrity Problem
2
2
Air/Gas in Device
2
2
Complete Loss of Power
2
2
Partial Blockage
2
2
No Audible Alarm
2
2
Alarm Not Visible
2
2
Coagulation in Device or Device Ingredient
2
2
Particulates
2
2
Failure to Run on Battery
2
2
Nonstandard Device
2
2
Gradient Increase
2
2
High Readings
2
2
Failure to Align
2
2
Visual Prompts will not Clear
2
2
Unable to Obtain Readings
2
2
Failure to Select Signal
1
1
Smoking
1
1
Material Separation
1
1
Shipping Damage or Problem
1
1
Decrease in Pressure
1
1
Failure to Prime
1
1
Off-Label Use
1
1
No Audible Prompt/Feedback
1
1
Device Damaged Prior to Use
1
1
Device Contamination with Body Fluid
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1021
1021
No Consequences Or Impact To Patient
281
281
No Patient Involvement
205
205
No Known Impact Or Consequence To Patient
175
175
Insufficient Information
98
98
Hemorrhage/Bleeding
63
63
Thrombosis/Thrombus
44
44
Death
42
42
Hemolysis
35
35
Cardiac Arrest
32
32
Heart Failure/Congestive Heart Failure
28
28
No Information
22
22
Thrombus
21
21
Low Oxygen Saturation
20
20
Bacterial Infection
18
18
Arrhythmia
17
17
Renal Failure
17
17
Thromboembolism
14
14
Multiple Organ Failure
14
14
Ischemia Stroke
13
13
Blood Loss
13
13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
12
12
Respiratory Failure
11
11
Stroke/CVA
11
11
Hypoxia
11
11
Unspecified Infection
11
11
Low Blood Pressure/ Hypotension
10
10
Atrial Fibrillation
10
10
Tachycardia
10
10
Cardiogenic Shock
10
10
Sepsis
8
8
Renal Impairment
8
8
Hematoma
7
7
Anemia
6
6
Intracranial Hemorrhage
6
6
Fungal Infection
5
5
Gastrointestinal Hemorrhage
5
5
Hemorrhagic Stroke
5
5
Hematuria
4
4
Respiratory Insufficiency
4
4
Lactate Dehydrogenase Increased
4
4
Reaction
4
4
Brain Injury
4
4
Right Ventricular Failure
4
4
Ventricular Fibrillation
4
4
Ischemia
4
4
Air Embolism
4
4
Bradycardia
4
4
Dyspnea
4
4
Encephalopathy
3
3
Liver Damage/Dysfunction
3
3
Hemothorax
3
3
High Blood Pressure/ Hypertension
3
3
Thrombosis
3
3
Septic Shock
3
3
Shock
3
3
Pain
3
3
Hypovolemia
3
3
Liver Failure
3
3
Obstruction/Occlusion
3
3
No Code Available
2
2
Convulsion/Seizure
2
2
Hydrocephalus
2
2
Thrombocytopenia
2
2
Aspiration Pneumonitis
2
2
Epistaxis
2
2
Kidney Infection
2
2
Drug Resistant Bacterial Infection
2
2
Unspecified Gastrointestinal Problem
2
2
Melena
2
2
Cardiac Tamponade
2
2
Complaint, Ill-Defined
2
2
Pleural Effusion
2
2
Visual Impairment
2
2
Muscle Weakness
2
2
Coagulation Disorder
2
2
Cardiopulmonary Arrest
2
2
Atrial Flutter
1
1
Exsanguination
1
1
Fever
1
1
Emotional Changes
1
1
Infarction, Cerebral
1
1
Myocardial Infarction
1
1
Necrosis
1
1
Memory Loss/Impairment
1
1
Inflammation
1
1
Failure of Implant
1
1
Hyperthermia
1
1
Hemorrhage, Cerebral
1
1
Loss of Vision
1
1
Vomiting
1
1
Heart Failure
1
1
Pneumothorax
1
1
Pulmonary Edema
1
1
Paralysis
1
1
Perforation
1
1
Respiratory Distress
1
1
Injury
1
1
Respiratory Tract Infection
1
1
Irritability
1
1
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 Cardiovascular Us Sales, Llc
II
Dec-12-2019
5
Maquet Medical Systems USA
II
Feb-02-2024
6
OriGen Biomedical, Inc.
II
Oct-30-2020
7
QURA S.R.L.
II
Aug-12-2021
8
Thoratec Switzerland GMBH
I
Oct-30-2019
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