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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
Device Problems
MDRs with this Device Problem
Events in those MDRs
Microbial Contamination of Device
1305
1305
Temperature Problem
254
254
Pumping Problem
221
221
Appropriate Term/Code Not Available
185
185
Electrical Shorting
165
165
Insufficient Cooling
135
135
Insufficient Heating
119
119
Fluid/Blood Leak
112
112
Device Displays Incorrect Message
99
99
Adverse Event Without Identified Device or Use Problem
51
51
Electrical /Electronic Property Problem
50
50
Smoking
43
43
Pumping Stopped
29
29
Infusion or Flow Problem
25
25
Device Emits Odor
24
24
Unexpected Shutdown
22
22
Contamination
21
21
Overheating of Device
20
20
Insufficient Information
20
20
No Flow
19
19
Failure to Pump
17
17
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
Mechanical Problem
10
10
Output Problem
9
9
Display or Visual Feedback Problem
9
9
Defective Component
9
9
Leak/Splash
9
9
Excessive Cooling
8
8
Loss of Power
8
8
Failure to Power Up
8
8
Device Issue
8
8
No Display/Image
8
8
Therapeutic or Diagnostic Output Failure
8
8
Defective Device
7
7
Break
7
7
Contamination /Decontamination Problem
7
7
Excessive Heating
7
7
Power Problem
6
6
Sparking
6
6
Circuit Failure
6
6
Use of Device Problem
6
6
Device Contamination with Chemical or Other Material
5
5
Device Sensing Problem
5
5
Incorrect, Inadequate or Imprecise Result or Readings
4
4
Gas Output Problem
4
4
Electrical Power Problem
4
4
Self-Activation or Keying
3
3
Insufficient Flow or Under Infusion
3
3
Calibration Problem
3
3
Difficult to Open or Close
3
3
No Apparent Adverse Event
3
3
Arcing
3
3
Product Quality Problem
3
3
Failure of Device to Self-Test
3
3
Fail-Safe Did Not Operate
3
3
Gas/Air Leak
3
3
Intermittent Loss of Power
3
3
Material Fragmentation
2
2
Protective Measures Problem
2
2
Complete Blockage
2
2
Missing Information
2
2
Material Integrity Problem
2
2
Corroded
2
2
False Alarm
2
2
Ambient Temperature Problem
2
2
Device Contamination With Biological Material
2
2
Image Display Error/Artifact
2
2
Improper Flow or Infusion
2
2
Detachment of Device or Device Component
2
2
Blocked Connection
2
2
Incorrect Measurement
2
2
Complete Loss of Power
2
2
Key or Button Unresponsive/not Working
2
2
Device Damaged Prior to Use
1
1
Loose or Intermittent Connection
1
1
Material Rupture
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Restricted Flow rate
1
1
Erratic or Intermittent Display
1
1
Filling Problem
1
1
Crack
1
1
Degraded
1
1
No Audible Alarm
1
1
Device Abrasion From Instrument Or Another Object
1
1
Component Missing
1
1
Failure to Calibrate
1
1
Electrical Overstress
1
1
Naturally Worn
1
1
Radiation Output Problem
1
1
Activation Problem
1
1
Unintended Collision
1
1
Energy Output Problem
1
1
Alarm Not Visible
1
1
Partial Blockage
1
1
Material Discolored
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1034
1034
No Patient Involvement
705
705
No Known Impact Or Consequence To Patient
591
591
No Consequences Or Impact To Patient
348
348
Bacterial Infection
274
274
Death
47
47
Insufficient Information
26
26
Unspecified Infection
22
22
No Information
11
11
Fatigue
9
9
Fever
9
9
Alteration in Body Temperature
8
8
Endocarditis
8
8
Weight Changes
6
6
Abscess
4
4
Sepsis
4
4
Hypothermia
3
3
Post Operative Wound Infection
3
3
Weakness
3
3
Abdominal Pain
3
3
Multiple Organ Failure
3
3
Malaise
2
2
Dyspnea
2
2
No Code Available
2
2
Bradycardia
2
2
Alteration In Body Temperature
2
2
Pneumonia
2
2
High Blood Pressure/ Hypertension
2
2
Erythema
2
2
Fainting
1
1
Hepatitis
1
1
Anemia
1
1
Aortic Insufficiency
1
1
Cardiopulmonary Arrest
1
1
Non specific EKG/ECG Changes
1
1
Thrombus
1
1
Numbness
1
1
Sweating
1
1
Abdominal Distention
1
1
Unspecified Gastrointestinal Problem
1
1
Pneumothorax
1
1
Ventricular Fibrillation
1
1
Vomiting
1
1
Atrial Fibrillation
1
1
Diarrhea
1
1
Granuloma
1
1
Hypoglycemia
1
1
Test Result
1
1
Lactate Dehydrogenase Increased
1
1
Infection, Indirect
1
1
Anxiety
1
1
Complaint, Ill-Defined
1
1
Ventilator Dependent
1
1
Pain
1
1
Pleural Effusion
1
1
Foreign Body In Patient
1
1
Patient Problem/Medical Problem
1
1
Not Applicable
1
1
Hemorrhage/Bleeding
1
1
Liver Damage/Dysfunction
1
1
Uveitis
1
1
Arthralgia
1
1
Disability
1
1
Diaphoresis
1
1
Unspecified Heart Problem
1
1
Renal Impairment
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Fall
1
1
Hypersensitivity/Allergic reaction
1
1
Inflammation
1
1
Misdiagnosis
1
1
Chills
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
CardioQuip, LLC
II
Oct-07-2021
2
CardioQuip, LLC
II
Oct-06-2021
3
Cincinnati Sub-Zero Products LLC
II
Feb-13-2018
4
Cincinnati Sub-Zero Products LLC, a Gentherm Company
II
Feb-13-2019
5
Cincinnati Sub-Zero Products LLC, a Gentherm Company
II
Oct-03-2018
6
Gentherm Medical, LLC
II
Jul-19-2021
7
LivaNova USA
II
May-18-2018
8
LivaNova USA Inc.
II
Mar-13-2020
9
LivaNova USA Inc.
II
Oct-25-2019
10
LivaNova USA Inc.
II
Apr-06-2019
11
Maquet Medical Systems USA
II
Jul-23-2021
12
Terumo Cardiovascular Systems Corporation
II
Jun-04-2021
13
Terumo Cardiovascular Systems Corporation
II
Apr-18-2018
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