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Device
controller, temperature, cardiopulmonary bypass
Definition
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product Code
DWC
Regulation Number
870.4250
Device Class
2
Premarket Reviews
Manufacturer
Decision
LIVANOVA DEUTSCHLAND GMBH
SUBSTANTIALLY EQUIVALENT
2
SPECTRUM MEDICAL LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
566
566
2019
697
697
2020
548
548
2021
622
622
2022
605
605
2023
806
806
Device Problems
MDRs with this Device Problem
Events in those MDRs
Microbial Contamination of Device
1909
1909
Temperature Problem
305
305
Pumping Problem
264
264
Electrical Shorting
189
189
Appropriate Term/Code Not Available
185
185
Insufficient Cooling
154
154
Insufficient Heating
130
130
Fluid/Blood Leak
120
120
Device Displays Incorrect Message
99
99
Adverse Event Without Identified Device or Use Problem
52
52
Electrical /Electronic Property Problem
51
51
Smoking
45
45
Pumping Stopped
35
35
No Flow
28
28
Insufficient Information
26
26
Infusion or Flow Problem
25
25
Device Emits Odor
24
24
Contamination
23
23
Unexpected Shutdown
23
23
Failure to Pump
22
22
Overheating of Device
21
21
Leak/Splash
18
18
Noise, Audible
17
17
Device Alarm System
15
15
Biofilm coating in Device
13
13
Melted
13
13
Thermal Decomposition of Device
12
12
Device Operates Differently Than Expected
11
11
Output Problem
10
10
Display or Visual Feedback Problem
10
10
Mechanical Problem
10
10
Defective Component
9
9
Device Issue
8
8
Loss of Power
8
8
Failure to Power Up
8
8
No Display/Image
8
8
Therapeutic or Diagnostic Output Failure
8
8
Excessive Cooling
8
8
Excessive Heating
7
7
Break
7
7
Defective Device
7
7
Contamination /Decontamination Problem
7
7
Sparking
6
6
Use of Device Problem
6
6
Circuit Failure
6
6
Power Problem
6
6
No Apparent Adverse Event
5
5
Device Sensing Problem
5
5
Device Contamination with Chemical or Other Material
5
5
Incorrect, Inadequate or Imprecise Result or Readings
5
5
Gas Output Problem
4
4
Labelling, Instructions for Use or Training Problem
4
4
Electrical Power Problem
4
4
Gas/Air Leak
3
3
Difficult to Open or Close
3
3
Failure of Device to Self-Test
3
3
Fail-Safe Did Not Operate
3
3
Complete Loss of Power
3
3
Intermittent Loss of Power
3
3
Self-Activation or Keying
3
3
Product Quality Problem
3
3
Ambient Temperature Problem
3
3
Calibration Problem
3
3
Arcing
3
3
Insufficient Flow or Under Infusion
3
3
Blocked Connection
2
2
Incorrect Measurement
2
2
Image Display Error/Artifact
2
2
Material Fragmentation
2
2
Complete Blockage
2
2
False Alarm
2
2
Erratic or Intermittent Display
2
2
Corroded
2
2
Missing Information
2
2
Key or Button Unresponsive/not Working
2
2
Detachment of Device or Device Component
2
2
Device Contamination With Biological Material
2
2
Improper Flow or Infusion
2
2
Material Integrity Problem
2
2
Protective Measures Problem
2
2
Pressure Problem
1
1
Operating System Becomes Nonfunctional
1
1
Unintended Movement
1
1
Patient Device Interaction Problem
1
1
Device Handling Problem
1
1
Material Twisted/Bent
1
1
Mechanical Jam
1
1
Naturally Worn
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Deformation
1
1
Device Operational Issue
1
1
Electrical Overstress
1
1
Unintended Application Program Shut Down
1
1
Activation Problem
1
1
Unintended Electrical Shock
1
1
No Visual Prompts/Feedback
1
1
Radiation Output Problem
1
1
Crack
1
1
Degraded
1
1
Material Discolored
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1722
1722
No Patient Involvement
705
705
No Known Impact Or Consequence To Patient
591
591
Bacterial Infection
374
374
No Consequences Or Impact To Patient
348
348
Death
47
47
Insufficient Information
40
40
Unspecified Infection
23
23
No Information
11
11
Fatigue
9
9
Fever
9
9
Endocarditis
8
8
Alteration in Body Temperature
8
8
Weight Changes
6
6
Abscess
4
4
Sepsis
4
4
Abdominal Pain
3
3
Hypothermia
3
3
Post Operative Wound Infection
3
3
Multiple Organ Failure
3
3
Weakness
3
3
Respiratory Tract Infection
2
2
Alteration In Body Temperature
2
2
Malaise
2
2
Unspecified Heart Problem
2
2
No Code Available
2
2
Pneumonia
2
2
Dyspnea
2
2
High Blood Pressure/ Hypertension
2
2
Bradycardia
2
2
Erythema
2
2
Fainting
1
1
Fall
1
1
Granuloma
1
1
Hearing Impairment
1
1
Hemorrhage/Bleeding
1
1
Hepatitis
1
1
Hypersensitivity/Allergic reaction
1
1
Cardiopulmonary Arrest
1
1
Diarrhea
1
1
Anemia
1
1
Aortic Insufficiency
1
1
Atrial Fibrillation
1
1
Hypoglycemia
1
1
Non specific EKG/ECG Changes
1
1
Inflammation
1
1
Liver Damage/Dysfunction
1
1
Pain
1
1
Pleural Effusion
1
1
Pneumothorax
1
1
Thrombus
1
1
Uveitis
1
1
Ventricular Fibrillation
1
1
Vomiting
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Unspecified Gastrointestinal Problem
1
1
Renal Impairment
1
1
Lactate Dehydrogenase Increased
1
1
Diaphoresis
1
1
Abdominal Distention
1
1
Test Result
1
1
Not Applicable
1
1
Disability
1
1
Impaired Healing
1
1
Ventilator Dependent
1
1
Numbness
1
1
Infection, Indirect
1
1
Anxiety
1
1
Complaint, Ill-Defined
1
1
Arthralgia
1
1
Foreign Body In Patient
1
1
Patient Problem/Medical Problem
1
1
Sweating
1
1
Misdiagnosis
1
1
Chills
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
CardioQuip, LLC
II
Dec-01-2023
2
CardioQuip, LLC
II
Oct-07-2021
3
CardioQuip, LLC
II
Oct-06-2021
4
Cincinnati Sub-Zero Products LLC
II
Feb-13-2018
5
Cincinnati Sub-Zero Products LLC, a Gentherm Company
II
Feb-13-2019
6
Cincinnati Sub-Zero Products LLC, a Gentherm Company
II
Oct-03-2018
7
Gentherm Medical, LLC
II
Jul-19-2021
8
LivaNova Deutschland GmbH
II
Oct-06-2023
9
LivaNova USA
II
May-18-2018
10
LivaNova USA Inc.
II
Mar-13-2020
11
LivaNova USA Inc.
II
Oct-25-2019
12
LivaNova USA Inc.
II
Apr-06-2019
13
Maquet Medical Systems USA
II
Jul-23-2021
14
Terumo Cardiovascular Systems Corporation
II
Jun-04-2021
15
Terumo Cardiovascular Systems Corporation
II
Apr-18-2018
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