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TPLC
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show TPLC since
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Device
warmer, thermal, infusion fluid
Product Code
LGZ
Regulation Number
880.5725
Device Class
2
Premarket Reviews
Manufacturer
Decision
BARKEY GMBH & CO. KG
SUBSTANTIALLY EQUIVALENT
1
LIFE WARMER, INC.
SUBSTANTIALLY EQUIVALENT
2
MAC MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
MEQU A/S
SUBSTANTIALLY EQUIVALENT
1
QUALITY IN FLOW LTD.
SUBSTANTIALLY EQUIVALENT
1
SMISSON-CARTLEDGE BIOMEDICAL LLC
SUBSTANTIALLY EQUIVALENT
1
THE SURGICAL COMPANY INTERNATIONAL B.V.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
340
340
2020
1221
1221
2021
885
885
2022
1548
1548
2023
1032
1032
2024
487
487
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
1228
1228
Leak/Splash
511
511
Device Alarm System
491
491
Temperature Problem
381
381
Display or Visual Feedback Problem
282
282
Crack
236
236
Break
211
211
Power Problem
177
177
Mechanical Problem
161
161
Defective Alarm
160
160
No Audible Alarm
160
160
Insufficient Heating
143
143
Overheating of Device
126
126
Electrical /Electronic Property Problem
111
111
Fracture
106
106
Failure to Power Up
106
106
Defective Component
105
105
False Alarm
105
105
Noise, Audible
95
95
No Display/Image
85
85
Failure to Pump
81
81
Excessive Heating
81
81
Pumping Problem
71
71
Connection Problem
63
63
Failure to Calibrate
57
57
Infusion or Flow Problem
52
52
Device Sensing Problem
46
46
Display Difficult to Read
45
45
Material Separation
44
44
Pressure Problem
42
42
Defective Device
42
42
Output Problem
38
38
Calibration Problem
37
37
Component Missing
37
37
Detachment of Device or Device Component
36
36
Audible Prompt/Feedback Problem
36
36
Device Damaged Prior to Use
36
36
Improper Flow or Infusion
35
35
Key or Button Unresponsive/not Working
33
33
Insufficient Flow or Under Infusion
30
30
Patient Device Interaction Problem
30
30
Alarm Not Visible
29
29
Circuit Failure
29
29
Smoking
28
28
Incorrect, Inadequate or Imprecise Result or Readings
26
26
Insufficient Information
26
26
No Flow
25
25
Failure to Sense
25
25
Failure to Deliver
24
24
Erratic or Intermittent Display
22
22
Corroded
20
20
Device Displays Incorrect Message
16
16
Air/Gas in Device
16
16
Image Display Error/Artifact
16
16
Fitting Problem
15
15
Increase in Pressure
15
15
Contamination
15
15
No Visual Prompts/Feedback
14
14
Material Twisted/Bent
14
14
Contamination /Decontamination Problem
13
13
Intermittent Loss of Power
13
13
Naturally Worn
13
13
Complete Loss of Power
12
12
Material Fragmentation
12
12
Failure of Device to Self-Test
12
12
Grounding Malfunction
11
11
Obstruction of Flow
11
11
Use of Device Problem
10
10
Appropriate Term/Code Not Available
10
10
Electrical Power Problem
10
10
Fire
10
10
Device Fell
10
10
No Audible Prompt/Feedback
10
10
Disconnection
10
10
Loose or Intermittent Connection
10
10
No Tactile Prompts/Feedback
10
10
Electrical Shorting
10
10
Poor Quality Image
9
9
Device Emits Odor
9
9
Electrical Overstress
9
9
Device Difficult to Maintain
9
9
Device Difficult to Setup or Prepare
9
9
No Apparent Adverse Event
9
9
Material Integrity Problem
8
8
Unable to Obtain Readings
8
8
Protective Measures Problem
8
8
Failure to Infuse
8
8
Manufacturing, Packaging or Shipping Problem
7
7
Low Readings
7
7
Flare or Flash
7
7
Material Discolored
7
7
Deformation Due to Compressive Stress
7
7
Material Split, Cut or Torn
7
7
Particulates
7
7
Degraded
6
6
Inaccurate Flow Rate
6
6
Failure to Cycle
6
6
Sparking
6
6
Failure to Conduct
6
6
Pumping Stopped
6
6
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2923
2923
Insufficient Information
1218
1218
No Information
737
737
No Patient Involvement
510
510
No Consequences Or Impact To Patient
309
309
No Known Impact Or Consequence To Patient
218
218
No Code Available
5
5
Death
5
5
Patient Problem/Medical Problem
4
4
Hypovolemic Shock
4
4
Urethral Stenosis/Stricture
3
3
Ruptured Aneurysm
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Ischemia
2
2
Bruise/Contusion
2
2
Exsanguination
2
2
Hemorrhage/Bleeding
2
2
Hypothermia
2
2
Aneurysm
2
2
Exposure to Body Fluids
1
1
Abrasion
1
1
Adhesion(s)
1
1
Burn(s)
1
1
Cardiac Arrest
1
1
Infiltration into Tissue
1
1
Electric Shock
1
1
Thrombosis/Thrombus
1
1
Skin Inflammation/ Irritation
1
1
Missing Value Reason
1
1
Not Applicable
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Eight Medical International BV
I
Jul-23-2021
2
RanD S.r.l.
II
Jul-09-2021
3
Smisson-Cartledge Biomedical, LLC
I
Mar-26-2021
4
Smiths Medical ASD Inc.
I
Sep-03-2021
5
Vyaire Medical
I
Jun-26-2019
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