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TPLC
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show TPLC since
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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
MDR Year
MDR Reports
MDR Events
2017
3129
3129
2018
5927
5927
2019
5972
5972
2020
4598
4598
2021
5076
5076
2022
1469
1469
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid Leak
12831
12831
Adverse Event Without Identified Device or Use Problem
5746
5746
Thermal Decomposition of Device
3054
3054
Overfill
1105
1105
Disconnection
877
877
Device Displays Incorrect Message
814
814
Protective Measures Problem
604
604
Loose or Intermittent Connection
588
588
Improper Flow or Infusion
328
328
Device Operates Differently Than Expected
294
294
Device Contamination with Chemical or Other Material
241
241
Detachment of Device or Device Component
221
221
Improper or Incorrect Procedure or Method
213
213
Material Puncture/Hole
162
162
Component Missing
136
136
Material Split, Cut or Torn
131
131
Hole In Material
117
117
Break
116
116
Device Handling Problem
94
94
Failure to Disconnect
87
87
Crack
86
86
Air/Gas in Device
86
86
Sparking
71
71
Overheating of Device
68
68
Fitting Problem
52
52
Smoking
46
46
Cut In Material
46
46
Connection Problem
43
43
Volume Accuracy Problem
43
43
Leak/Splash
39
39
Grounding Malfunction
28
28
Incomplete or Inadequate Connection
27
27
Melted
24
24
Device Issue
18
18
Material Deformation
18
18
Scratched Material
16
16
Unintended Electrical Shock
16
16
Use of Device Problem
16
16
Material Separation
13
13
Material Perforation
12
12
Misassembled
12
12
Material Rupture
11
11
Electrical /Electronic Property Problem
9
9
Excessive Heating
8
8
Material Integrity Problem
7
7
Filling Problem
7
7
Air Leak
7
7
Bent
7
7
Fire
5
5
Image Display Error/Artifact
5
5
Tear, Rip or Hole in Device Packaging
5
5
Detachment Of Device Component
4
4
Contamination
4
4
Component Misassembled
4
4
Appropriate Term/Code Not Available
3
3
Electrical Shorting
3
3
Temperature Problem
3
3
Device Alarm System
3
3
Misconnection
3
3
Mechanical Problem
3
3
Product Quality Problem
3
3
Intermittent Shock/Stimulation
3
3
Device Inoperable
2
2
Device Contamination with Body Fluid
2
2
Arcing
2
2
Device Dislodged or Dislocated
2
2
Device Operational Issue
2
2
Delivered as Unsterile Product
2
2
Device Emits Odor
2
2
Kinked
2
2
Power Problem
2
2
Material Twisted/Bent
2
2
Insufficient Information
2
2
Noise, Audible
2
2
Unexpected Color
2
2
Incomplete or Inadequate Priming
1
1
Separation Problem
1
1
Unexpected Shutdown
1
1
No Flow
1
1
Environmental Compatibility Problem
1
1
Free or Unrestricted Flow
1
1
Gas Leak
1
1
Infusion or Flow Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Torn Material
1
1
Unintended Movement
1
1
Moisture Damage
1
1
Unsealed Device Packaging
1
1
Failure to Power Up
1
1
Failure to Prime
1
1
No Audible Alarm
1
1
Partial Blockage
1
1
Corroded
1
1
Charred
1
1
Restricted Flow rate
1
1
Display Difficult to Read
1
1
Display or Visual Feedback Problem
1
1
Difficult to Open or Close
1
1
Calibration Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
11131
11132
No Clinical Signs, Symptoms or Conditions
4276
4276
No Consequences Or Impact To Patient
3674
3674
Peritonitis
3321
3321
Abdominal Pain
1189
1189
No Patient Involvement
776
776
Death
443
443
Dyspnea
407
407
Hypervolemia
384
384
Unspecified Infection
360
360
Hernia
354
354
Nausea
276
276
Abdominal Distention
262
262
Vomiting
233
233
No Information
194
194
Pain
159
159
Cardiac Arrest
151
151
Insufficient Information
146
146
Discomfort
140
140
Increased Intra-Peritoneal Volume (IIPV)
138
138
Low Blood Pressure/ Hypotension
113
113
Diarrhea
104
104
Sepsis
103
103
Chest Pain
101
101
Constipation
101
101
Fever
99
99
High Blood Pressure/ Hypertension
92
92
Electrolyte Imbalance
92
92
No Code Available
85
85
Confusion/ Disorientation
72
72
Pulmonary Edema
68
68
Pneumonia
66
66
Myocardial Infarction
60
60
Weakness
59
59
Edema
59
59
Swelling
53
53
Pleural Effusion
51
51
Uremia
43
43
Malaise
43
43
Blood Loss
41
41
Congestive Heart Failure
39
39
Respiratory Failure
37
37
Anemia
32
32
Stroke/CVA
32
32
Dizziness
29
29
Fatigue
28
28
Hypoxia
27
27
Weight Changes
27
27
Loss of consciousness
26
26
Chills
26
26
Hyperglycemia
25
25
Bacterial Infection
24
24
Dehydration
24
24
Swelling/ Edema
24
24
Cardiopulmonary Arrest
23
23
Hypoglycemia
22
22
Fall
22
22
Cramp(s)
22
22
Respiratory Distress
22
22
Syncope
20
20
Urinary Tract Infection
19
19
Seizures
18
18
Encephalopathy
18
18
Atrial Fibrillation
17
17
Hypovolemia
17
17
Injury
14
14
Hemorrhage/Bleeding
12
12
Inflammation
11
11
Pericardial Effusion
11
11
Chest Tightness/Pressure
11
11
Abdominal Cramps
11
11
Arrhythmia
10
10
Fungus
9
9
Septic Shock
9
9
Tachycardia
8
8
Lethargy
8
8
Obstruction/Occlusion
7
7
Fungal Infection
7
7
Heart Failure/Congestive Heart Failure
7
7
Heart Failure
7
7
Headache
7
7
Cellulitis
6
6
Shaking/Tremors
6
6
Bowel Perforation
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
Bradycardia
5
5
Abscess
5
5
Itching Sensation
5
5
Bone Fracture(s)
5
5
Transient Ischemic Attack
4
4
Burning Sensation
4
4
Hematoma
4
4
Pulmonary Embolism
4
4
Angina
4
4
Bronchitis
4
4
Convulsion/Seizure
4
4
Electric Shock
4
4
Diaphoresis
4
4
Sudden Cardiac Death
4
4
Reaction
3
3
Recalls
Manufacturer
Recall Class
Date Posted
1
BAXTER HEALTHCARE CORPORATION
II
Aug-02-2021
2
Baxter Healthcare Corp
II
Sep-14-2017
3
Baxter Healthcare Corporation
II
Oct-03-2019
4
Baxter Healthcare Corporation
II
Feb-20-2019
5
Baxter Healthcare Corporation
II
Aug-02-2018
6
Baxter Healthcare Corporation
II
Aug-16-2017
7
Baxter Healthcare Corporation
II
Jan-19-2017
8
Fresenius Medical Care Holdings, Inc.
II
Jul-16-2021
9
Fresenius Medical Care Holdings, Inc.
II
Nov-07-2020
10
Fresenius Medical Care Renal Therapies Group, LLC
II
Aug-05-2019
11
Fresenius Medical Care Renal Therapies Group, LLC
II
Apr-12-2018
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