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 Code	PHC
Regulation Number	880.5725
Device Class	2

Premarket Reviews
Manufacturer	Decision
BAXTER HEALTHCARE CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
BECTON DICKINSON
	SUBSTANTIALLY EQUIVALENT	1
1. K243062 BD Intelliport System; BD Intelliport Reader (5162 ...
FRESENIUS KABI AG
	SUBSTANTIALLY EQUIVALENT	1
ICU MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
No Apparent Adverse Event	14	14
Computer System Security Problem	11	13
Computer Software Problem	10	10
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	70	75
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	Dec-19-2025
6	ICU Medical, Inc.	II	Dec-19-2025
7	ICU Medical, Inc.	II	May-14-2025
8	Ivenix, Inc.	II	Jul-13-2022