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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
BAIN MEDICAL EQUIPMENT(GUANGZHOU) CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
DIMESOL, INC.
SUBSTANTIALLY EQUIVALENT
1
FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE
SUBSTANTIALLY EQUIVALENT
1
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
SUBSTANTIALLY EQUIVALENT
1
GAMBRO RENAL PRODUCTS, INC.
SUBSTANTIALLY EQUIVALENT
1
HOME DIALYSIS PLUS
SUBSTANTIALLY EQUIVALENT
1
JIANGXI SANXIN MEDTEC CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
NIPRO MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
NXSTAGE MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
OUTSET MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
OXYLESS LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
113
113
2015
126
126
2016
139
139
2017
131
131
2018
119
119
2019
185
185
2020
190
190
2021
188
188
2022
362
362
2023
585
585
2024
282
282
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
975
975
Leak/Splash
396
396
Air/Gas in Device
292
292
Adverse Event Without Identified Device or Use Problem
210
210
Detachment of Device or Device Component
197
197
Material Puncture/Hole
179
179
Disconnection
79
79
Crack
61
61
Insufficient Information
49
49
Loose or Intermittent Connection
46
46
Contamination /Decontamination Problem
30
30
Connection Problem
27
27
Air Leak
24
24
Obstruction of Flow
23
23
Break
20
20
Occlusion Within Device
17
17
Detachment Of Device Component
16
16
Material Separation
16
16
Material Deformation
16
16
Device Dislodged or Dislocated
15
15
Device Operates Differently Than Expected
12
12
Misconnection
11
11
Kinked
11
11
Degraded
10
10
Separation Problem
9
9
Material Split, Cut or Torn
9
9
Defective Component
9
9
Hole In Material
8
8
No Fail-Safe Mechanism
8
8
Device Displays Incorrect Message
7
7
Pressure Problem
6
6
Inadequate Filtration Process
6
6
Device Contamination with Chemical or Other Material
6
6
Improper Flow or Infusion
6
6
Material Rupture
6
6
Migration or Expulsion of Device
5
5
Material Perforation
5
5
Gas/Air Leak
5
5
Failure To Adhere Or Bond
5
5
Improper or Incorrect Procedure or Method
5
5
Component Missing
4
4
Coagulation in Device or Device Ingredient
4
4
Increase in Pressure
4
4
Device Alarm System
4
4
Device Operational Issue
4
4
Use of Device Problem
3
3
Device Handling Problem
3
3
Patient-Device Incompatibility
3
3
Filtration Problem
3
3
Torn Material
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
939
939
No Known Impact Or Consequence To Patient
513
513
Hemorrhage/Bleeding
396
396
Blood Loss
160
160
Death
82
82
No Consequences Or Impact To Patient
79
79
Low Blood Pressure/ Hypotension
63
63
Cardiac Arrest
56
56
Hemolysis
55
55
Loss of consciousness
41
41
Cardiopulmonary Arrest
35
35
Insufficient Information
34
34
Dyspnea
22
22
Chest Pain
18
18
Exsanguination
18
18
Anemia
15
15
Hypovolemia
13
13
Syncope
13
13
Abdominal Pain
11
11
Nausea
11
11
Hypersensitivity/Allergic reaction
10
10
High Blood Pressure/ Hypertension
9
9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
9
9
Bradycardia
9
9
Dizziness
9
9
Vomiting
8
8
No Code Available
8
8
No Patient Involvement
8
8
Loss Of Pulse
7
7
Myocardial Infarction
6
6
Air Embolism
6
6
Seizures
5
5
Hypoxia
5
5
Malaise
5
5
Diaphoresis
5
5
Confusion/ Disorientation
5
5
Itching Sensation
5
5
Pain
4
4
Tachycardia
4
4
Headache
4
4
Low Oxygen Saturation
4
4
Peritonitis
4
4
Hypervolemia
4
4
Pulmonary Embolism
4
4
Cramp(s) /Muscle Spasm(s)
4
4
Syncope/Fainting
4
4
Shaking/Tremors
3
3
Anxiety
3
3
Reaction
3
3
Unspecified Infection
3
3
Recalls
Manufacturer
Recall Class
Date Posted
1
B Braun Medical Inc
II
Sep-19-2024
2
Baxter Healthcare Corporation
II
May-26-2021
3
Baxter Healthcare Corporation
II
Feb-16-2021
4
Baxter Healthcare Corporation
II
Jun-01-2020
5
Fresenius Medical Care Holdings, Inc.
I
Jan-10-2011
6
Gambro Renal Products, Incorporated
II
Apr-11-2014
7
ICU Medical, Inc.
II
Dec-23-2020
8
Nipro Medical Corporation
II
May-15-2018
9
Nipro Medical Corporation
II
Jan-08-2016
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