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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 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
Use of Device Problem 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
Failure to Infuse 1 1
Obstruction of Flow 1 1
Application Program Version or Upgrade Problem 1 1
Battery Problem 1 1
Data Problem 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Insufficient Information 1 1
Protective Measures Problem 1 1
Improper Flow or Infusion 1 1
Installation-Related Problem 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 10 10
No Patient Involvement 3 3
No Known Impact Or Consequence To Patient 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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