TPLC - Total Product Life Cycle

• Device: flowmeter, blood, cardiovascular
• Regulation Description: Cardiovascular blood flowmeter.
• Product Code: DPW
• Regulation Number: 870.2100
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ELFI-TECH LTD.
	SUBSTANTIALLY EQUIVALENT	1
FLOSONICS MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
FLOSONICS MEDICAL (R/A 1929803 ONTARIO CORP.)
	SUBSTANTIALLY EQUIVALENT	1
KOVEN TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	1
LASER ASSOCIATED SCIENCES, INC.
	SUBSTANTIALLY EQUIVALENT	1
REMINGTON MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
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SYNOVIS MICRO COMPANIES ALLIANCE, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	4	4
2021	6	6
2022	1	1
2023	2	2
2024	4	4
2025	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Output Problem	3	3
Difficult to Open or Close	3	3
Break	2	2
Structural Problem	2	2
Disconnection	1	1
Fitting Problem	1	1
Device Alarm System	1	1
Insufficient Information	1	1
Therapeutic or Diagnostic Output Failure	1	1
Failure to Align	1	1
Detachment of Device or Device Component	1	1
Device Sensing Problem	1	1
Protective Measures Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	11	11
Insufficient Information	4	4
Patient Problem/Medical Problem	1	1
No Known Impact Or Consequence To Patient	1	1
Aneurysm	1	1
No Consequences Or Impact To Patient	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Baxter Healthcare Corporation	II	Jul-20-2023