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TPLC - Total Product Life Cycle
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Device infusion safety management software
Definition Infusion safety management software is a prescription device intended for use with infusion pumps and may include one or more of the following capabilities: prepopulation of infusion programming parameters, data retrieval and analysis for tracking and trending, drug infusion error reduction algorithms, and alarm transmission.
Product CodePHC
Regulation Number 880.5725
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
BECTON DICKINSON & CO.
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON, AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS KABI AG
  SUBSTANTIALLY EQUIVALENT 1
ICU MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITHS MEDICAL ASD, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1 1
2017 1 1
2018 1 1
2019 3 3
2020 2 2
2021 35 35
2022 4 4
2023 9 9
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Communication or Transmission Problem 8 8
Computer Software Problem 6 6
Wireless Communication Problem 5 5
Failure to Read Input Signal 5 5
Computer System Security Problem 5 5
Failure to Transmit Record 4 4
No Apparent Adverse Event 4 4
Break 3 3
Appropriate Term/Code Not Available 3 3
Operating System Becomes Nonfunctional 3 3
Use of Device Problem 2 2
Excess Flow or Over-Infusion 2 2
Insufficient Flow or Under Infusion 2 2
Failure to Infuse 2 2
Application Program Problem 2 2
Device Alarm System 2 2
Intermittent Communication Failure 2 2
Application Program Version or Upgrade Problem 1 1
Insufficient Information 1 1
Battery Problem 1 1
Application Program Problem: Medication Error 1 1
Improper Flow or Infusion 1 1
Obstruction of Flow 1 1
Inaccurate Flow Rate 1 1
Data Problem 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Protective Measures Problem 1 1
Defective Alarm 1 1
Defective Component 1 1
Product Quality Problem 1 1
Incorrect Measurement 1 1
Installation-Related Problem 1 1
Programming Issue 1 1
Device Displays Incorrect Message 1 1
Pumping Stopped 1 1
Failure to Deliver 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 48 48
No Consequences Or Impact To Patient 11 11
No Known Impact Or Consequence To Patient 4 4
No Patient Involvement 3 3
No Information 1 1
Insufficient Information 1 1
Low Blood Pressure/ Hypotension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Oct-13-2018
2 Becton Dickinson & Company II Mar-08-2016
3 CareFusion 303, Inc. II Sep-03-2020
4 Fenwal Inc I Aug-12-2019
5 Fresenius Kabi USA, LLC I Oct-06-2022
6 Ivenix, Inc. II Jul-13-2022
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