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U.S. Department of Health and Human Services

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, AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS KABI AG
  SUBSTANTIALLY EQUIVALENT 1
ICU MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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
Failure to Read Input Signal 5 5
Wireless Communication Problem 5 5
Computer System Security Problem 5 5
Failure to Transmit Record 4 4
No Apparent Adverse Event 4 4
Operating System Becomes Nonfunctional 3 3
Break 3 3
Appropriate Term/Code Not Available 3 3
Application Program Problem 2 2
Device Alarm System 2 2
Use of Device Problem 2 2
Excess Flow or Over-Infusion 2 2
Intermittent Communication Failure 2 2
Insufficient Information 1 1
Application Program Version or Upgrade Problem 1 1
Defective Component 1 1
Battery Problem 1 1
Obstruction of Flow 1 1
Improper Flow or Infusion 1 1
Data Problem 1 1
Defective Alarm 1 1
Failure to Infuse 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Protective Measures Problem 1 1
Inaccurate Flow Rate 1 1
Pumping Stopped 1 1
Failure to Deliver 1 1
Product Quality Problem 1 1
Installation-Related Problem 1 1
Incorrect Measurement 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 10 10
No Known Impact Or Consequence To Patient 3 3
No Patient Involvement 3 3
Insufficient Information 1 1
Low Blood Pressure/ Hypotension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CareFusion 303, Inc. II Sep-03-2020
2 Fenwal Inc I Aug-12-2019
3 Fresenius Kabi USA, LLC I Oct-06-2022
4 Ivenix, Inc. II Jul-13-2022
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