Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device pump, infusion, pca
Product CodeMEA
Regulation Number 880.5725
Device Class 2

MDR Year MDR Reports MDR Events
2019 131 131
2020 2331 2331
2021 3775 3775
2022 6443 6443
2023 3984 3984
2024 738 738

Device Problems MDRs with this Device Problem Events in those MDRs
Break 5957 5957
Crack 4444 4444
Corroded 3889 3889
Device Markings/Labelling Problem 3869 3869
Failure to Align 2482 2482
Contamination 1630 1630
Appropriate Term/Code Not Available 987 987
Device Alarm System 907 907
Deformation Due to Compressive Stress 848 848
Physical Resistance/Sticking 784 784
No Apparent Adverse Event 721 721
Naturally Worn 662 662
Failure to Calibrate 600 600
Inaccurate Delivery 579 579
Device Sensing Problem 570 570
Display Difficult to Read 563 563
Computer Software Problem 517 517
Circuit Failure 381 381
Misassembled 353 353
Excess Flow or Over-Infusion 282 282
Insufficient Information 272 272
Calibration Problem 249 249
Application Program Freezes, Becomes Nonfunctional 245 245
Degraded 240 240
Volume Accuracy Problem 201 201
Insufficient Flow or Under Infusion 183 183
Failure to Analyze Signal 178 178
Communication or Transmission Problem 150 150
Display or Visual Feedback Problem 145 145
Infusion or Flow Problem 120 120
Failure to Read Input Signal 117 117
Obstruction of Flow 48 48
Use of Device Problem 47 47
Air/Gas in Device 45 45
Audible Prompt/Feedback Problem 44 44
Mechanical Problem 43 43
Component Misassembled 42 42
Output Problem 38 38
Pumping Stopped 36 36
Electrical /Electronic Property Problem 36 36
Inaccurate Flow Rate 36 36
Improper Flow or Infusion 34 34
Connection Problem 34 34
Failure to Deliver 32 32
Battery Problem 31 31
Failure to Sense 28 28
Material Integrity Problem 27 27
Peeled/Delaminated 25 25
Failure to Power Up 24 24
No Display/Image 24 24
Fail-Safe Problem 24 24
Application Program Problem 24 24
Missing Information 19 19
False Alarm 18 18
Contamination /Decontamination Problem 17 17
Component Missing 16 16
Defective Alarm 16 16
Loose or Intermittent Connection 15 15
Failure to Infuse 15 15
Mechanics Altered 15 15
Defective Component 14 14
Adverse Event Without Identified Device or Use Problem 13 13
Device Misassembled During Manufacturing /Shipping 12 12
Product Quality Problem 12 12
Power Problem 11 11
Complete Blockage 10 10
Failure to Cycle 10 10
No Audible Alarm 9 9
Device Difficult to Maintain 9 9
Partial Blockage 8 8
Fluid/Blood Leak 8 8
Device Slipped 8 8
Incorrect Measurement 8 8
Pressure Problem 8 8
No Flow 8 8
Pumping Problem 8 8
Blocked Connection 8 8
Loss of Data 8 8
Detachment of Device or Device Component 8 8
Application Program Version or Upgrade Problem 7 7
Defective Device 7 7
Improper or Incorrect Procedure or Method 7 7
Increase in Pressure 7 7
Failure to Charge 7 7
Failure to Pump 6 6
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Device Displays Incorrect Message 6 6
Inaccurate Information 6 6
Key or Button Unresponsive/not Working 6 6
Intermittent Loss of Power 5 5
Wireless Communication Problem 5 5
Failure to Prime 5 5
Leak/Splash 5 5
Loss of Power 5 5
Nonstandard Device 5 5
Material Discolored 4 4
Computer Operating System Problem 4 4
No Audible Prompt/Feedback 4 4
Protective Measures Problem 4 4
Lack of Maintenance Documentation or Guidelines 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13023 13023
No Patient Involvement 3414 3414
Insufficient Information 967 967
No Information 133 133
No Consequences Or Impact To Patient 115 115
No Known Impact Or Consequence To Patient 52 52
Pain 17 17
Fall 6 6
Oversedation 5 5
Low Oxygen Saturation 5 5
Numbness 4 4
Death 4 4
Hypoglycemia 4 4
Low Blood Pressure/ Hypotension 3 3
Cardiac Arrest 3 3
Underdose 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Inadequate Pain Relief 3 3
Lethargy 2 2
Decreased Respiratory Rate 2 2
Syncope/Fainting 2 2
High Blood Pressure/ Hypertension 2 2
Bradycardia 2 2
Hypoxia 2 2
Nausea 2 2
Overdose 2 2
Fever 1 1
Respiratory Distress 1 1
Vomiting 1 1
Dizziness 1 1
Muscle Weakness 1 1
Bruise/Contusion 1 1
Coma 1 1
Diaphoresis 1 1
Discomfort 1 1
Injury 1 1
Hypoesthesia 1 1
Paresthesia 1 1
Pulmonary Hypertension 1 1
Respiratory Insufficiency 1 1
Unspecified Respiratory Problem 1 1
Increased Respiratory Rate 1 1

Recalls
Manufacturer Recall Class Date Posted
1 B Braun Medical Inc II Mar-22-2022
-
-