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TPLC
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show TPLC since
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Device
supplies, blood-bank
Product Code
KSS
Regulation Number
864.9050
Device Class
1
Premarket Reviews
Manufacturer
Decision
FRESENIUS KABI AG
SUBSTANTIALLY EQUIVALENT
1
FRESENIUS KABI USA LLC.
SUBSTANTIALLY EQUIVALENT
1
ITL CORPORATION PTY, LTD
SUBSTANTIALLY EQUIVALENT
1
MACOPRODUCTIONS S.A.S.
SUBSTANTIALLY EQUIVALENT
2
TIMESTRIP UK LTD.
SUBSTANTIALLY EQUIVALENT
2
TYPENEX MEDICAL LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
6
6
2015
1
1
2016
8
8
2017
3
3
2018
10
10
2019
11
11
2020
2
2
2021
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Difficult to Setup or Prepare
7
7
Insufficient Information
5
5
Separation Problem
4
4
Fracture
3
3
Delivered as Unsterile Product
2
2
Mechanical Problem
2
2
Incorrect Or Inadequate Test Results
2
2
Inadequacy of Device Shape and/or Size
2
2
Leak/Splash
2
2
Separation Failure
2
2
False Negative Result
2
2
Material Separation
1
1
Pressure Problem
1
1
Break
1
1
Crack
1
1
Improper Flow or Infusion
1
1
Output Problem
1
1
Noise, Audible
1
1
Filling Problem
1
1
Fluid/Blood Leak
1
1
Shipping Damage or Problem
1
1
Particulates
1
1
Appropriate Term/Code Not Available
1
1
Device Operational Issue
1
1
Tear, Rip or Hole in Device Packaging
1
1
Material Integrity Problem
1
1
Contamination
1
1
Device Contamination with Body Fluid
1
1
Improper or Incorrect Procedure or Method
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Information
10
10
No Code Available
8
8
No Patient Involvement
8
8
No Known Impact Or Consequence To Patient
7
7
No Consequences Or Impact To Patient
5
5
Unspecified Infection
3
3
Laceration(s)
2
2
No Clinical Signs, Symptoms or Conditions
2
2
Pain
1
1
Swelling
1
1
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