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TPLC
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Device
accessories, pump, infusion
Regulation Description
Infusion pump.
Product Code
MRZ
Regulation Number
880.5725
Device Class
2
Premarket Reviews
Manufacturer
Decision
B. BRAUN MELSUGEN AG
SUBSTANTIALLY EQUIVALENT
1
CHENGDU SHIFENG MEDICAL TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
ELITE BIOMEDICAL SOLUTIONS
SUBSTANTIALLY EQUIVALENT
1
GILERO, LLC
SUBSTANTIALLY EQUIVALENT
1
WELLDOC, INC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
44
44
2021
59
59
2022
39
39
2023
27
27
2024
38
38
2025
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Alarm System
37
37
Wireless Communication Problem
26
26
Computer Software Problem
14
14
Infusion or Flow Problem
13
13
Patient Device Interaction Problem
10
10
Excess Flow or Over-Infusion
7
7
Protective Measures Problem
6
6
Break
5
5
Material Integrity Problem
5
5
Failure to Infuse
5
5
Volume Accuracy Problem
4
4
Air/Gas in Device
4
4
Overheating of Device
4
4
Charging Problem
4
4
Insufficient Flow or Under Infusion
4
4
Battery Problem
4
4
Mechanical Problem
4
4
Device Contamination with Chemical or Other Material
3
3
Device Displays Incorrect Message
3
3
Improper Flow or Infusion
3
3
Display or Visual Feedback Problem
3
3
Defective Device
3
3
Insufficient Information
3
3
Packaging Problem
3
3
Fluid/Blood Leak
3
3
Communication or Transmission Problem
2
2
Circuit Failure
2
2
Inaccurate Flow Rate
2
2
Failure to Calibrate
2
2
Problem with Software Installation
2
2
Intermittent Communication Failure
2
2
Product Quality Problem
2
2
Activation, Positioning or Separation Problem
2
2
Leak/Splash
2
2
Free or Unrestricted Flow
2
2
Power Problem
2
2
No Audible Alarm
2
2
Crack
2
2
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Output Problem
2
2
Failure to Sense
1
1
Loose or Intermittent Connection
1
1
Defective Component
1
1
Appropriate Term/Code Not Available
1
1
Failure to Cycle
1
1
Electrical /Electronic Property Problem
1
1
Physical Resistance/Sticking
1
1
Low Audible Alarm
1
1
Complete Blockage
1
1
Audible Prompt/Feedback Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
104
104
Insufficient Information
48
48
No Consequences Or Impact To Patient
19
19
No Patient Involvement
15
15
No Information
13
13
Pain
6
6
Swelling/ Edema
5
5
Erythema
5
5
No Known Impact Or Consequence To Patient
2
2
High Blood Pressure/ Hypertension
2
2
Unspecified Infection
2
2
Endocarditis
2
2
Overdose
2
2
Headache
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Chemical Exposure
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Smiths Medical ASD Inc.
II
Apr-15-2024
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