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TPLC
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Device
set, i.v. fluid transfer
Product Code
LHI
Regulation Number
880.5440
Device Class
2
Premarket Reviews
Manufacturer
Decision
ADVCARE MEDICAL
SUBSTANTIALLY EQUIVALENT
1
AEA SRL
SUBSTANTIALLY EQUIVALENT
1
AVENIR PERFORMANCE EUROPEENNE MEDICAL (APEM)
SUBSTANTIALLY EQUIVALENT
2
AVENIR PERFORMANCE EUROPÉENNE MEDICAL (APEM)
SUBSTANTIALLY EQUIVALENT
1
B. BRAUN MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
CAREFUSION
SUBSTANTIALLY EQUIVALENT
1
FRESENIUS KABI AG
SUBSTANTIALLY EQUIVALENT
1
GCMEDICA ENTERPRISE LTD., (WUXI)
SUBSTANTIALLY EQUIVALENT
1
HANGZHOU QIANTANG LONGYUE BIOTECHNOLOGY CO., LTD
SUBSTANTIALLY EQUIVALENT
1
ICU MEDICAL
SUBSTANTIALLY EQUIVALENT
1
IPAX, INC
SUBSTANTIALLY EQUIVALENT
1
JIANGSU CAINA MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
OMNICELL, INC.
SUBSTANTIALLY EQUIVALENT
1
SFM MEDICAL DEVICES GMBH
SUBSTANTIALLY EQUIVALENT
1
SHANGHAI LING FU TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SOL-MILLENNIUM MEDICAL GROUP
SUBSTANTIALLY EQUIVALENT
1
WEST PHARMA SERVICES IL, LTD.
SUBSTANTIALLY EQUIVALENT
5
WEST PHARMACEUTICAL SERVICES AZ, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
1633
1789
2020
1167
1167
2021
923
923
2022
1836
1836
2023
1048
1048
2024
129
129
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
3473
3561
Device Contamination with Chemical or Other Material
1158
1220
Device Displays Incorrect Message
252
252
Leak/Splash
224
224
Infusion or Flow Problem
204
204
Break
142
142
Protective Measures Problem
139
139
Defective Device
111
111
Material Puncture/Hole
106
106
Contamination /Decontamination Problem
105
105
Disconnection
90
95
Defective Component
80
80
Device Alarm System
78
78
Nonstandard Device
75
75
Free or Unrestricted Flow
73
73
Output Problem
64
64
Air/Gas in Device
59
59
Therapeutic or Diagnostic Output Failure
49
49
Detachment of Device or Device Component
39
39
Difficult to Open or Close
35
35
Improper Flow or Infusion
28
28
No Flow
26
26
Display or Visual Feedback Problem
26
26
Contamination
25
25
Loose or Intermittent Connection
23
23
Crack
21
21
Unsealed Device Packaging
21
23
Component Missing
16
16
Pressure Problem
15
15
Connection Problem
13
13
Device Difficult to Setup or Prepare
13
13
Backflow
12
12
Noise, Audible
12
12
Material Twisted/Bent
12
12
Illegible Information
12
12
Material Split, Cut or Torn
11
11
Gas/Air Leak
11
11
Complete Blockage
11
11
Pumping Stopped
11
11
Use of Device Problem
11
11
Fitting Problem
11
11
Insufficient Flow or Under Infusion
10
10
Material Separation
10
10
Failure to Align
10
10
Patient Device Interaction Problem
10
10
Material Rupture
9
9
Product Quality Problem
9
9
Increase in Pressure
9
9
Tear, Rip or Hole in Device Packaging
9
9
Inaccurate Delivery
8
8
Failure to Prime
8
8
Mechanical Problem
8
8
Packaging Problem
8
8
Obstruction of Flow
8
8
Device Markings/Labelling Problem
8
8
Material Deformation
8
8
Pumping Problem
7
7
Adverse Event Without Identified Device or Use Problem
7
7
Insufficient Information
7
7
Material Discolored
7
7
Precipitate in Device or Device Ingredient
7
7
Material Perforation
7
7
Volume Accuracy Problem
7
7
Improper or Incorrect Procedure or Method
7
7
Particulates
6
6
Activation Failure
6
6
Incomplete or Inadequate Connection
6
6
Priming Problem
6
6
Device Contaminated During Manufacture or Shipping
6
6
Manufacturing, Packaging or Shipping Problem
6
6
Material Protrusion/Extrusion
5
5
Audible Prompt/Feedback Problem
5
5
Failure to Infuse
5
5
Delivered as Unsterile Product
5
5
Filling Problem
5
5
Labelling, Instructions for Use or Training Problem
4
4
Material Opacification
4
4
Misassembled
4
4
Defective Alarm
4
4
Device Slipped
4
4
Device Damaged Prior to Use
4
4
Reflux within Device
4
5
Appropriate Term/Code Not Available
4
4
Structural Problem
4
4
Difficult or Delayed Activation
4
4
Failure to Deliver
4
4
Expiration Date Error
3
3
Material Integrity Problem
3
3
Component Misassembled
3
3
Scratched Material
3
3
Device Fell
3
3
Unexpected Shutdown
3
3
Unable to Obtain Readings
3
3
Failure to Power Up
3
3
False Alarm
3
3
Partial Blockage
3
6
Restricted Flow rate
3
3
Inaccurate Flow Rate
3
3
Material Fragmentation
2
2
Excess Flow or Over-Infusion
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
3152
3152
No Patient Involvement
2260
2356
Insufficient Information
480
480
No Consequences Or Impact To Patient
389
393
No Known Impact Or Consequence To Patient
251
307
Dyspnea
33
33
Headache
27
27
No Information
22
22
Dizziness
16
16
Pain
14
14
Fatigue
11
11
Diarrhea
11
11
Nausea
10
10
Chest Pain
8
8
Malaise
8
8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
8
8
Unspecified Infection
7
7
Chemical Exposure
5
5
Hot Flashes/Flushes
4
4
Vomiting
3
3
Tachycardia
3
3
Anxiety
3
3
Arrhythmia
3
3
Swelling/ Edema
3
3
Unspecified Respiratory Problem
3
3
Cough
3
3
Respiratory Insufficiency
2
2
Decreased Appetite
2
2
Hypervolemia
2
2
Syncope/Fainting
2
2
Electrolyte Imbalance
2
2
Premature Labor
2
2
Low Oxygen Saturation
2
2
Abdominal Pain
2
2
Purulent Discharge
2
2
Itching Sensation
2
2
Hypoglycemia
2
2
Low Blood Pressure/ Hypotension
2
2
Hypoxia
2
2
Sepsis
2
2
Skin Discoloration
1
1
Swelling
1
1
Pneumonia
1
1
Rash
1
1
Red Eye(s)
1
1
Discomfort
1
1
Arthralgia
1
1
Vertigo
1
1
Muscle Weakness
1
1
Fever
1
1
Hemorrhage/Bleeding
1
1
Erythema
1
1
Adult Respiratory Distress Syndrome
1
1
Anemia
1
1
Cardiac Arrest
1
1
Stroke/CVA
1
1
Shaking/Tremors
1
1
Underdose
1
1
Pallor
1
1
Diaphoresis
1
1
Taste Disorder
1
1
Heart Failure/Congestive Heart Failure
1
1
Foreign Body In Patient
1
1
Blood Loss
1
1
Weight Changes
1
1
Pulmonary Hypertension
1
1
Gastroesophageal Burn
1
1
Unspecified Gastrointestinal Problem
1
1
Skin Inflammation/ Irritation
1
1
Contact Dermatitis
1
1
Unspecified Tissue Injury
1
1
Peripheral Edema
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
B. Braun Medical, Inc.
II
Mar-07-2022
2
Baxter Healthcare Corporation
I
Feb-16-2024
3
Baxter Healthcare Corporation
II
Aug-24-2022
4
Baxter Healthcare Corporation
II
Oct-21-2019
5
International Medical Industries, Inc.
II
Jan-07-2023
6
WEST PHARMA. SERVICES IL, LTD
I
Jan-28-2019
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