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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 37
2022 4 4
2023 9 12
2024 11 11
2025 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
No Apparent Adverse Event 13 13
Computer System Security Problem 11 13
Computer Software Problem 9 9
Communication or Transmission 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 4
Break 3 3
Use of Device Problem 3 3
Data Problem 3 3
Installation-Related Problem 3 4
Appropriate Term/Code Not Available 3 5
Device Alarm System 2 2
Application Program Problem 2 3
No Audible Alarm 2 2
Failure to Deliver 2 2
Obstruction of Flow 2 2
Excess Flow or Over-Infusion 2 2
Insufficient Flow or Under Infusion 2 2
Failure to Infuse 2 2
Intermittent Communication Failure 2 2
Application Program Version or Upgrade Problem 1 1
Insufficient Information 1 2
Defective Component 1 1
Pumping Stopped 1 1
Battery Problem 1 1
Blocked Connection 1 1
Infusion or Flow Problem 1 1
Incorrect Measurement 1 1
Product Quality Problem 1 1
Defective Alarm 1 1
Inaccurate Delivery 1 1
Protective Measures Problem 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Intermittent Program or Algorithm Execution 1 1
No Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 69 74
No Consequences Or Impact To Patient 10 10
No Patient Involvement 3 3
Low Blood Pressure/ Hypotension 3 3
Oversedation 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation I Jul-17-2025
2 CareFusion 303, Inc. I Mar-13-2025
3 CareFusion 303, Inc. II Sep-03-2020
4 Fresenius Kabi USA, LLC I Oct-06-2022
5 ICU Medical, Inc. II May-14-2025
6 Ivenix, Inc. II Jul-13-2022
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