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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 2 2

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 46 46
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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