TPLC - Total Product Life Cycle

show TPLC since

Device	flowmeter, blood, cardiovascular
Product Code	DPW
Regulation Number	870.2100
Device Class	2

Premarket Reviews
Manufacturer	Decision
COOK VASCULAR, INC.
	SUBSTANTIALLY EQUIVALENT	1
DELTEX MEDICAL LIMITED
	SUBSTANTIALLY EQUIVALENT	4
EM-TEC GMBH
	SUBSTANTIALLY EQUIVALENT	1
FLOSONICS MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
FLOSONICS MEDICAL (R/A 1929803 ONTARIO CORP.)
	SUBSTANTIALLY EQUIVALENT	2
HUNTLEIGH HEALTHCARE LTD
	SUBSTANTIALLY EQUIVALENT	1
KOVEN TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	1
LASER ASSOCIATED SCIENCES, INC.
	SUBSTANTIALLY EQUIVALENT	2
MEDI-STIM ASA
	SUBSTANTIALLY EQUIVALENT	1
MOOR INSTRUMENTS LTD.
	SUBSTANTIALLY EQUIVALENT	1
OR-NIM MEDICAL LTD.
	SUBSTANTIALLY EQUIVALENT	2
PERIMED AB
	SUBSTANTIALLY EQUIVALENT	1
REMINGTON MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
RFPI
	SUBSTANTIALLY EQUIVALENT	1
SYNOVIS MICRO COMPANIES ALLIANCE, INC.
	SUBSTANTIALLY EQUIVALENT	1
TRANSONIC SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2
VASAMED, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Displays Incorrect Message	14	14
Output Problem	5	5
Break	4	4
Defective Device	3	3
Pumping Stopped	3	3
Difficult to Open or Close	3	3
Insufficient Information	2	2
Out-Of-Box Failure	2	2
Structural Problem	2	2
Device Operates Differently Than Expected	2	2
Electrical /Electronic Property Problem	2	2
Disconnection	1	1
Leak/Splash	1	1
Fitting Problem	1	1
Device Alarm System	1	1
Crack	1	1
Therapeutic or Diagnostic Output Failure	1	1
Failure to Power Up	1	1
Improper Flow or Infusion	1	1
Device Sensing Problem	1	1
Protective Measures Problem	1	1
Inappropriate or Unexpected Reset	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	14	14
No Clinical Signs, Symptoms or Conditions	10	10
No Patient Involvement	8	8
Insufficient Information	4	4
No Consequences Or Impact To Patient	4	4
No Information	2	2
Patient Problem/Medical Problem	1	1
Aneurysm	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Baxter Healthcare Corp.	II	May-10-2016
2	Baxter Healthcare Corporation	II	Jul-20-2023
3	Baxter Healthcare Corporation	II	Jul-29-2014
4	Escalon Medical Corp	II	Oct-22-2010
5	Medistim Asa	II	Feb-26-2018
6	Parks Medical Electronics, Inc	II	Dec-10-2012
7	Transonic Systems Inc	II	Sep-03-2015
8	Vascular Technology, Inc.	II	Sep-12-2018
9	Vascular Technology, Inc.	II	Jul-07-2014