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TPLC
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Device
system, peritoneal, automatic delivery
Product Code
FKX
Regulation Number
876.5630
Device Class
2
Premarket Reviews
Manufacturer
Decision
BAXTER HEALTHCARE CORPORATION
SUBSTANTIALLY EQUIVALENT
1
CLOUDCATH
SUBSTANTIALLY EQUIVALENT
1
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
SUBSTANTIALLY EQUIVALENT
4
LIBERDI, LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
5927
5927
2019
5972
5972
2020
4598
4598
2021
5076
5076
2022
4504
4504
2023
1244
1244
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
13455
13455
Adverse Event Without Identified Device or Use Problem
6137
6137
Thermal Decomposition of Device
3508
3508
Overfill
1044
1044
Disconnection
845
845
Protective Measures Problem
747
747
Loose or Intermittent Connection
586
586
Device Displays Incorrect Message
465
465
Improper Flow or Infusion
328
328
Detachment of Device or Device Component
242
242
Device Contamination with Chemical or Other Material
237
237
Material Puncture/Hole
198
198
Device Operates Differently Than Expected
194
194
Air/Gas in Device
167
167
Material Split, Cut or Torn
164
164
Component Missing
155
155
Break
114
114
Failure to Disconnect
114
114
Improper or Incorrect Procedure or Method
106
106
Crack
97
97
Sparking
80
80
Fitting Problem
65
65
Smoking
47
47
Incomplete or Inadequate Connection
36
36
Scratched Material
29
29
Unintended Electrical Shock
27
27
Connection Problem
26
26
Hole In Material
26
26
Melted
24
24
Overheating of Device
22
22
Cut In Material
19
19
Material Deformation
17
17
Volume Accuracy Problem
14
14
Material Separation
13
13
Grounding Malfunction
12
12
Material Perforation
12
12
Device Handling Problem
10
10
Excessive Heating
9
9
Material Rupture
9
9
Leak/Splash
7
7
Component Misassembled
6
6
Material Twisted/Bent
6
6
Fire
6
6
Material Integrity Problem
6
6
Image Display Error/Artifact
5
5
Device Issue
5
5
Filling Problem
5
5
Tear, Rip or Hole in Device Packaging
4
4
Electrical /Electronic Property Problem
4
4
Use of Device Problem
3
3
Intermittent Shock/Stimulation
3
3
Product Quality Problem
3
3
Mechanical Problem
3
3
Defective Device
2
2
Noise, Audible
2
2
Device Alarm System
2
2
Device Emits Odor
2
2
Arcing
2
2
Electrical Shorting
2
2
Unintended Movement
2
2
Unexpected Color
2
2
Misconnection
2
2
Device Contamination with Body Fluid
2
2
Bent
2
2
Device Dislodged or Dislocated
2
2
Therapeutic or Diagnostic Output Failure
2
2
Delivered as Unsterile Product
2
2
Contamination /Decontamination Problem
1
1
Appropriate Term/Code Not Available
1
1
No Flow
1
1
Shipping Damage or Problem
1
1
Obstruction of Flow
1
1
Difficult to Open or Close
1
1
Gas/Air Leak
1
1
Fracture
1
1
Failure to Prime
1
1
Failure to Sense
1
1
Operating System Becomes Nonfunctional
1
1
Device Inoperable
1
1
Electro-Static Discharge
1
1
Defective Component
1
1
False Alarm
1
1
Contamination
1
1
Corroded
1
1
Display Difficult to Read
1
1
Detachment Of Device Component
1
1
Unsealed Device Packaging
1
1
Material Protrusion/Extrusion
1
1
Unexpected Shutdown
1
1
Restricted Flow rate
1
1
Free or Unrestricted Flow
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Audible Prompt/Feedback Problem
1
1
Incomplete or Inadequate Priming
1
1
Separation Problem
1
1
Temperature Problem
1
1
Insufficient Information
1
1
Calibration Problem
1
1
Display or Visual Feedback Problem
1
1
Charred
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
9900
9901
No Clinical Signs, Symptoms or Conditions
7177
7177
Peritonitis
3627
3627
No Consequences Or Impact To Patient
2850
2850
Abdominal Pain
1543
1543
No Patient Involvement
705
705
Unspecified Infection
500
500
Dyspnea
370
370
Hernia
339
339
Death
316
316
Hypervolemia
314
314
Insufficient Information
294
294
Nausea
290
290
Abdominal Distention
269
269
Vomiting
230
230
Increased Intra-Peritoneal Volume (IIPV)
216
216
No Information
186
186
Pain
156
156
Cardiac Arrest
147
147
Discomfort
117
117
Constipation
104
104
Diarrhea
100
100
Fever
97
97
Low Blood Pressure/ Hypotension
95
95
Chest Pain
84
84
Sepsis
83
83
High Blood Pressure/ Hypertension
74
74
Confusion/ Disorientation
66
66
Pulmonary Edema
65
65
Electrolyte Imbalance
58
58
No Code Available
55
55
Malaise
54
54
Pneumonia
51
51
Myocardial Infarction
50
50
Weakness
49
49
Edema
41
41
Swelling/ Edema
40
40
Swelling
39
39
Pleural Effusion
36
36
Uremia
32
32
Blood Loss
30
30
Fungal Infection
28
28
Loss of consciousness
28
28
Chills
28
28
Respiratory Failure
27
27
Weight Changes
27
27
Congestive Heart Failure
27
27
Dizziness
26
26
Stroke/CVA
26
26
Fatigue
26
26
Hypoxia
25
25
Dehydration
23
23
Bacterial Infection
21
21
Cramp(s)
21
21
Fall
20
20
Hypoglycemia
20
20
Cardiopulmonary Arrest
20
20
Hypovolemia
19
19
Hyperglycemia
19
19
Anemia
17
17
Heart Failure/Congestive Heart Failure
16
16
Seizures
13
13
Urinary Tract Infection
13
13
Atrial Fibrillation
13
13
Syncope
12
12
Septic Shock
12
12
Respiratory Distress
11
11
Lethargy
10
10
Inflammation
10
10
Encephalopathy
10
10
Fungus
9
9
Hypersensitivity/Allergic reaction
9
9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
9
9
Convulsion/Seizure
9
9
Arrhythmia
9
9
Tachycardia
9
9
Vertigo
8
8
Hemorrhage/Bleeding
8
8
Hematoma
7
7
Bowel Perforation
7
7
Bradycardia
6
6
Cellulitis
6
6
Pericardial Effusion
6
6
Abdominal Cramps
6
6
Headache
6
6
Shaking/Tremors
6
6
Injury
5
5
Viral Infection
5
5
Adhesion(s)
5
5
Angina
5
5
Burning Sensation
5
5
Bone Fracture(s)
4
4
Heart Failure
4
4
Diaphoresis
4
4
Obstruction/Occlusion
4
4
Electric Shock
4
4
Peritoneal Laceration(s)
4
4
Renal Failure
3
3
Transient Ischemic Attack
3
3
Arteriosclerosis/ Atherosclerosis
3
3
Recalls
Manufacturer
Recall Class
Date Posted
1
BAXTER HEALTHCARE CORPORATION
II
Aug-02-2021
2
Baxter Healthcare Corporation
II
Apr-01-2023
3
Baxter Healthcare Corporation
II
May-27-2022
4
Baxter Healthcare Corporation
II
Oct-03-2019
5
Baxter Healthcare Corporation
II
Feb-20-2019
6
Baxter Healthcare Corporation
II
Aug-02-2018
7
Fresenius Medical Care Holdings, Inc.
II
Jul-16-2021
8
Fresenius Medical Care Holdings, Inc.
II
Nov-07-2020
9
Fresenius Medical Care Renal Therapies Group, LLC
II
Aug-05-2019
10
Fresenius Medical Care Renal Therapies Group, LLC
II
Apr-12-2018
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