TPLC - Total Product Life Cycle

• Device: automated pipetting, diluting and specimen processing workstations for flow cytometric analysis
• Definition: Flow cytometer specimen processors are automated or semi-automated workstations designed to be used alone or in combination with manual methods to pipette, dilute and process human specimens in preparation for flow cytometric analysis.
• Product Code: PER
• Regulation Number: 862.2750
• Device Class: 1

Premarket Reviews
Manufacturer	Decision
BECKMAN COULTER, INC.
	SUBSTANTIALLY EQUIVALENT	1
BECTON DICKINSON & CO.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	2	2
2015	1	1
2016	2	2
2020	37	37
2021	54	54
2022	63	63
2023	11	11
2024	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	125	125
Incorrect, Inadequate or Imprecise Result or Readings	21	21
Leak/Splash	10	10
Mechanical Problem	3	3
Failure to Sense	3	3
Contamination	3	3
Device Operates Differently Than Expected	2	2
Device Contamination with Chemical or Other Material	2	2
Free or Unrestricted Flow	1	1
Infusion or Flow Problem	1	1
Mechanical Jam	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Output Problem	1	1
Non Reproducible Results	1	1
Break	1	1
Excess Flow or Over-Infusion	1	1
Fitting Problem	1	1
Failure to Deliver	1	1
Overfill	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	135	135
No Consequences Or Impact To Patient	21	21
No Patient Involvement	21	21
No Known Impact Or Consequence To Patient	2	2
Not Applicable	1	1
Abrasion	1	1
Exposure to Body Fluids	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Beckman Coulter Inc.	II	Jul-07-2017
2	Becton, Dickinson and Company, BD Biosciences	II	Jun-11-2020
3	Sysmex America, Inc.	II	Jul-22-2020