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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
Regulation Description Infusion pump.
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
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS KABI AG
  SUBSTANTIALLY EQUIVALENT 1
ICU MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 2 2
2021 35 35
2022 4 4
2023 9 9
2024 11 11
2025 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
No Apparent Adverse Event 10 10
Computer System Security Problem 10 10
Communication or Transmission Problem 8 8
Computer Software Problem 8 8
Failure to Read Input Signal 5 5
Wireless Communication Problem 5 5
Failure to Transmit Record 4 4
Operating System Becomes Nonfunctional 3 3
Break 3 3
Installation-Related Problem 3 3
Appropriate Term/Code Not Available 3 3
Application Program Problem 2 2
Use of Device Problem 2 2
Excess Flow or Over-Infusion 2 2
Data Problem 2 2
Intermittent Communication Failure 2 2
Device Alarm System 1 1
Application Program Version or Upgrade Problem 1 1
Insufficient Information 1 1
Defective Component 1 1
Pumping Stopped 1 1
Failure to Deliver 1 1
Battery Problem 1 1
Insufficient Flow or Under Infusion 1 1
Infusion or Flow Problem 1 1
Incorrect Measurement 1 1
Product Quality Problem 1 1
Defective Alarm 1 1
Failure to Infuse 1 1
Protective Measures Problem 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Intermittent Program or Algorithm Execution 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 61 61
No Consequences Or Impact To Patient 10 10
No Patient Involvement 3 3
Low Blood Pressure/ Hypotension 2 2
Oversedation 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CareFusion 303, Inc. I Mar-13-2025
2 CareFusion 303, Inc. II Sep-03-2020
3 Fresenius Kabi USA, LLC I Oct-06-2022
4 ICU Medical, Inc. II May-14-2025
5 Ivenix, Inc. II Jul-13-2022
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