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TPLC
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Device
apparatus, autotransfusion
Product Code
CAC
Regulation Number
868.5830
Device Class
2
Premarket Reviews
Manufacturer
Decision
ATRIUM MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
FRESENIUS KABI AG
SUBSTANTIALLY EQUIVALENT
2
HAEMONETICS CORPORATION
SUBSTANTIALLY EQUIVALENT
1
INARI MEDICAL
SUBSTANTIALLY EQUIVALENT
1
INARI MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
2
PROCELL SURGICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
SISU GLOBAL HEALTH
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
64
64
2020
108
108
2021
73
73
2022
65
65
2023
39
39
2024
8
8
Device Problems
MDRs with this Device Problem
Events in those MDRs
Crack
76
76
Fluid/Blood Leak
68
68
Material Integrity Problem
29
29
Mechanical Problem
19
19
Adverse Event Without Identified Device or Use Problem
17
17
Insufficient Information
17
17
Device Misassembled During Manufacturing /Shipping
15
15
Nonstandard Device
15
15
Deformation Due to Compressive Stress
13
13
Leak/Splash
12
12
Obstruction of Flow
11
11
Material Deformation
11
11
Gas/Air Leak
8
8
Material Puncture/Hole
8
8
Electrical /Electronic Property Problem
6
6
Appropriate Term/Code Not Available
6
6
Suction Problem
6
6
Contamination /Decontamination Problem
5
5
Infusion or Flow Problem
5
5
Device Alarm System
5
5
No Apparent Adverse Event
5
5
Break
4
4
Improper or Incorrect Procedure or Method
4
4
Material Twisted/Bent
4
4
Noise, Audible
4
4
Therapeutic or Diagnostic Output Failure
3
3
Component Missing
3
3
Defective Device
3
3
Disconnection
3
3
Physical Resistance/Sticking
3
3
Use of Device Problem
2
2
Self-Activation or Keying
2
2
Smoking
2
2
Delivered as Unsterile Product
2
2
Thermal Decomposition of Device
2
2
Burst Container or Vessel
2
2
Loose or Intermittent Connection
2
2
Defective Component
2
2
Connection Problem
2
2
Optical Problem
2
2
Output Problem
1
1
Pressure Problem
1
1
Protective Measures Problem
1
1
Temperature Problem
1
1
No Flow
1
1
No Pressure
1
1
Material Split, Cut or Torn
1
1
Device Markings/Labelling Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Device Contamination with Body Fluid
1
1
Calibration Problem
1
1
Chemical Problem
1
1
Microbial Contamination of Device
1
1
Insufficient Flow or Under Infusion
1
1
Device Displays Incorrect Message
1
1
Blocked Connection
1
1
Incorrect Measurement
1
1
Misconnection
1
1
Fracture
1
1
Excess Flow or Over-Infusion
1
1
Inadequate Instructions for Healthcare Professional
1
1
Contamination
1
1
Filling Problem
1
1
Decrease in Suction
1
1
Overheating of Device
1
1
Unsealed Device Packaging
1
1
Off-Label Use
1
1
Product Quality Problem
1
1
Reflux within Device
1
1
Difficult to Remove
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Increase in Suction
1
1
Inadequacy of Device Shape and/or Size
1
1
Volume Accuracy Problem
1
1
Sharp Edges
1
1
Application Program Freezes, Becomes Nonfunctional
1
1
Unclear Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
150
150
No Known Impact Or Consequence To Patient
60
60
No Patient Involvement
31
31
No Consequences Or Impact To Patient
29
29
Hemorrhage/Bleeding
25
25
Insufficient Information
14
14
Unspecified Blood or Lymphatic problem
12
12
No Information
8
8
Death
8
8
Blood Loss
7
7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
Hypovolemia
4
4
Pneumothorax
3
3
Cardiac Arrest
3
3
Hemolysis
3
3
Low Blood Pressure/ Hypotension
2
2
Pleural Effusion
2
2
Respiratory Distress
2
2
Foreign Body In Patient
2
2
No Code Available
1
1
Thrombus
1
1
Ruptured Aneurysm
1
1
Aspiration Pneumonitis
1
1
Cough
1
1
Blister
1
1
Unspecified Infection
1
1
Local Reaction
1
1
Low Oxygen Saturation
1
1
Sudden Cardiac Death
1
1
Skin Tears
1
1
Cognitive Changes
1
1
Hemothorax
1
1
Dyspnea
1
1
Pulmonary Embolism
1
1
Air Embolism
1
1
Bradycardia
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Atrium Medical Corporation
II
Dec-28-2023
2
Atrium Medical Corporation
II
Dec-02-2023
3
Atrium Medical Corporation
II
Nov-16-2023
4
Fenwal Inc
II
Apr-23-2019
5
Fenwal Inc
II
Mar-26-2019
6
Haemonetics Corporation
II
Jan-29-2020
7
Haemonetics Corporation
II
Jan-28-2019
8
Maquet Cardiovascular, LLC
I
Jan-12-2024
9
Medtronic Perfusion Systems
II
Jan-29-2019
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