TPLC - Total Product Life Cycle

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Device	transducer, blood-pressure, extravascular
Regulation Description	Extravascular blood pressure transducer.
Product Code	DRS
Regulation Number	870.2850
Device Class	2

Premarket Reviews
Manufacturer	Decision
B. BRAUN MELSUNGEN AG
	SUBSTANTIALLY EQUIVALENT	1
BIOMETRIX LTD.
	SUBSTANTIALLY EQUIVALENT	1
CENTURION MEDICAL PRODUCTS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
EDWARDS LIFESCIENCES, LLC
	SUBSTANTIALLY EQUIVALENT	2
ELCAM MEDICAL A.C.A.L
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MERIT MEDICAL PTE. LTD.
	SUBSTANTIALLY EQUIVALENT	1
MIRADOR BIOMEDICAL
	SUBSTANTIALLY EQUIVALENT	1
MIRADOR BIOMEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
REAVILLMED
	SUBSTANTIALLY EQUIVALENT	1
SMITHS MEDICAL ASD, INC.
	SUBSTANTIALLY EQUIVALENT	2
ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Separation	155	155
Fluid/Blood Leak	154	154
Disconnection	118	118
Leak/Splash	109	109
Break	74	74
Incorrect, Inadequate or Imprecise Result or Readings	69	69
Detachment Of Device Component	48	48
Separation Failure	29	29
Detachment of Device or Device Component	26	26
Separation Problem	26	26
Air/Gas in Device	23	23
Crack	22	22
Inaccurate Information	20	20
No Flow	17	17
Incorrect Measurement	16	16
Unable to Obtain Readings	14	14
High Readings	13	13
Pressure Problem	13	13
Air Leak	12	12
Connection Problem	11	11
Device Contamination with Chemical or Other Material	11	11
Infusion or Flow Problem	8	8
Output Problem	8	8
Material Split, Cut or Torn	8	8
Device Operates Differently Than Expected	7	7
Backflow	7	7
Loss of or Failure to Bond	7	7
Device Issue	7	7
Particulates	7	7
Failure to Reset	6	6
Mechanical Problem	6	6
Display or Visual Feedback Problem	6	6
Failure to Zero	5	5
Reflux within Device	5	5
Device Sensing Problem	5	5
Device Markings/Labelling Problem	5	5
Material Integrity Problem	4	4
Device Displays Incorrect Message	4	4
Difficult to Insert	4	4
Loose or Intermittent Connection	4	4
Difficult to Flush	3	3
No Device Output	3	3
Electrical /Electronic Property Problem	3	3
Contamination	3	3
Defective Device	3	3
Inappropriate Waveform	3	3
Tear, Rip or Hole in Device Packaging	3	3
Obstruction of Flow	3	3
Failure to Calibrate	3	3
Failure to Prime	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	539	539
No Consequences Or Impact To Patient	295	295
No Known Impact Or Consequence To Patient	85	85
Blood Loss	43	44
Hemorrhage/Bleeding	32	32
No Patient Involvement	30	30
Insufficient Information	24	24
No Information	11	11
Death	4	4
Low Blood Pressure/ Hypotension	4	4
Not Applicable	3	3
Exposure to Body Fluids	3	3
Cardiac Arrest	2	2
Thrombosis/Thrombus	2	2
Discomfort	2	2
Extravasation	2	2
Patient Problem/Medical Problem	1	1
Air Embolism	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Complaint, Ill-Defined	1	1
Pneumothorax	1	1
Anemia	1	1
Chronic Obstructive Pulmonary Disease (COPD)	1	1
Burn(s)	1	1
Extubate	1	1
Respiratory Insufficiency	1	1
Atrial Flutter	1	1
Full thickness (Third Degree) Burn	1	1
Device Embedded In Tissue or Plaque	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Argon Medical Devices, Inc	II	Nov-05-2019
2	Edwards Lifesciences, LLC	II	Nov-29-2023
3	Edwards Lifesciences, LLC	II	Sep-11-2013
4	ICU Medical, Inc.	II	Mar-28-2019
5	ICU Medical, Inc.	II	Nov-15-2016
6	ICU Medical, Inc.	II	Sep-15-2016
7	ICU Medical, Inc.	II	Aug-07-2014
8	MEDLINE INDUSTRIES, LP - Northfield	II	Mar-21-2025
9	Smiths Medical ASD Inc.	II	Apr-21-2021
10	Smiths Medical Asd Inc	II	Jan-17-2024
11	Utah Medical Products, Inc	II	Jun-13-2013