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TPLC
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show TPLC since
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Device
set, tubing, blood, with and without anti-regurgitation valve
Product Code
FJK
Regulation Number
876.5820
Device Class
2
Premarket Reviews
Manufacturer
Decision
BAIN MEDICAL EQUIPMENT(GUANGZHOU) CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
SUBSTANTIALLY EQUIVALENT
1
JIANGXI SANXIN MEDTEC CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
OUTSET MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
185
185
2020
190
190
2021
188
188
2022
362
362
2023
585
585
2024
119
119
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
696
696
Air/Gas in Device
277
277
Leak/Splash
274
274
Detachment of Device or Device Component
166
166
Material Puncture/Hole
144
144
Adverse Event Without Identified Device or Use Problem
55
55
Disconnection
37
37
Contamination /Decontamination Problem
29
29
Loose or Intermittent Connection
27
27
Crack
20
20
Obstruction of Flow
20
20
Break
18
18
Material Deformation
16
16
Degraded
10
10
Material Split, Cut or Torn
9
9
Separation Problem
8
8
Defective Component
6
6
Improper or Incorrect Procedure or Method
5
5
Inadequate Filtration Process
5
5
Material Separation
5
5
Device Contamination with Chemical or Other Material
5
5
Connection Problem
5
5
Gas/Air Leak
4
4
No Fail-Safe Mechanism
4
4
Component Missing
4
4
Device Alarm System
3
3
Output Problem
3
3
Pressure Problem
3
3
Improper Flow or Infusion
3
3
Material Twisted/Bent
2
2
Failure of Device to Self-Test
2
2
Defective Device
2
2
Protective Measures Problem
2
2
No Flow
2
2
Material Rupture
2
2
Tear, Rip or Hole in Device Packaging
2
2
No Audible Alarm
2
2
Loss of Power
2
2
Inflation Problem
1
1
Use of Device Problem
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Failure to Deliver
1
1
Fitting Problem
1
1
Defective Alarm
1
1
Complete Blockage
1
1
Coagulation in Device or Device Ingredient
1
1
Contamination
1
1
Nonstandard Device
1
1
Delivered as Unsterile Product
1
1
Power Conditioning Problem
1
1
Display or Visual Feedback Problem
1
1
Unintended Ejection
1
1
Inaccurate Flow Rate
1
1
Incomplete or Inadequate Connection
1
1
Pumping Problem
1
1
Temperature Problem
1
1
Insufficient Information
1
1
Device Handling Problem
1
1
Noise, Audible
1
1
Patient-Device Incompatibility
1
1
Structural Problem
1
1
Device Dislodged or Dislocated
1
1
Filtration Problem
1
1
Infusion or Flow Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
845
845
Hemorrhage/Bleeding
330
330
No Known Impact Or Consequence To Patient
266
266
No Consequences Or Impact To Patient
42
42
Insufficient Information
31
31
Blood Loss
29
29
Low Blood Pressure/ Hypotension
29
29
Hemolysis
18
18
Cardiac Arrest
16
16
Loss of consciousness
14
14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
9
9
Dizziness
8
8
Anemia
8
8
Exsanguination
8
8
Hypersensitivity/Allergic reaction
6
6
Death
6
6
Dyspnea
6
6
No Patient Involvement
5
5
Low Oxygen Saturation
4
4
Cramp(s) /Muscle Spasm(s)
4
4
Syncope/Fainting
4
4
Chest Pain
4
4
Itching Sensation
4
4
Hypovolemia
4
4
Nausea
3
3
Cardiopulmonary Arrest
3
3
Syncope
3
3
Bradycardia
3
3
No Code Available
3
3
Convulsion/Seizure
2
2
Loss Of Pulse
2
2
Chemical Exposure
2
2
Hypervolemia
2
2
Decreased Respiratory Rate
2
2
Confusion/ Disorientation
2
2
Anxiety
2
2
Malaise
2
2
Congestive Heart Failure
2
2
High Blood Pressure/ Hypertension
2
2
Abdominal Pain
2
2
Air Embolism
2
2
Hypoxia
2
2
Vomiting
2
2
Weakness
1
1
Jaundice
1
1
Peritonitis
1
1
Hemolytic Anemia
1
1
Anaphylactoid
1
1
Convulsion, Tonic
1
1
Pain
1
1
Rash
1
1
Seizures
1
1
Headache
1
1
Hypovolemic Shock
1
1
Angina
1
1
Coagulation Disorder
1
1
Hyperthermia
1
1
Obstruction/Occlusion
1
1
Diaphoresis
1
1
Lethargy
1
1
Sudden Cardiac Death
1
1
Foreign Body In Patient
1
1
Thrombosis/Thrombus
1
1
Cough
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Baxter Healthcare Corporation
II
May-26-2021
2
Baxter Healthcare Corporation
II
Feb-16-2021
3
Baxter Healthcare Corporation
II
Jun-01-2020
4
ICU Medical, Inc.
II
Dec-23-2020
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