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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	185	185
Material Separation	128	128
Disconnection	65	65
Break	57	57
Incorrect, Inadequate or Imprecise Result or Readings	47	47
Air/Gas in Device	39	39
Incorrect Measurement	34	34
Crack	32	32
No Flow	29	29
Separation Failure	28	28
Separation Problem	25	25
Inaccurate Information	25	25
Detachment of Device or Device Component	19	19
Unable to Obtain Readings	18	18
Leak/Splash	13	13
High Readings	13	13
Pressure Problem	11	11
Low Readings	9	9
Material Split, Cut or Torn	8	8
Device Sensing Problem	6	6
Material Integrity Problem	6	6
Connection Problem	5	5
Device Markings/Labelling Problem	5	5
Obstruction of Flow	5	5
Backflow	5	5
Device Contamination with Chemical or Other Material	4	4
Gas/Air Leak	4	4
Contamination	4	4
Failure to Zero	4	4
Inappropriate Waveform	4	4
Complete Blockage	4	4
Output Problem	4	4
Defective Device	3	3
Difficult to Insert	3	3
Loose or Intermittent Connection	3	3
Electrical /Electronic Property Problem	3	3
Improper Flow or Infusion	3	3
Mechanical Problem	3	3
Calibration Problem	3	3
Difficult to Flush	3	3
Defective Component	2	2
Loss of or Failure to Bond	2	2
Deformation Due to Compressive Stress	2	2
Device Displays Incorrect Message	2	2
Particulates	2	2
Reflux within Device	2	2
Material Rupture	2	2
Material Puncture/Hole	2	2
Display Difficult to Read	2	2
Incomplete or Inadequate Connection	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	721	721
Hemorrhage/Bleeding	51	51
Insufficient Information	29	29
Low Blood Pressure/ Hypotension	3	3
Air Embolism	2	2
High Blood Pressure/ Hypertension	2	2
Thrombosis/Thrombus	2	2
Discomfort	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Perinatal Brain Injury	1	1
Ischemia	1	1
Chemical Exposure	1	1
Skin Discoloration	1	1
Burn(s)	1	1
Needle Stick/Puncture	1	1
Exposure to Body Fluids	1	1
Vomiting	1	1
Extravasation	1	1
Blurred Vision	1	1
Headache	1	1
Loss of Vision	1	1
No Consequences Or Impact To Patient	1	1
Respiratory Insufficiency	1	1
Full thickness (Third Degree) Burn	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Edwards Lifesciences, LLC	II	Nov-29-2023
2	MEDLINE INDUSTRIES, LP - Northfield	II	Mar-21-2025
3	Medline Industries, LP	I	May-08-2026
4	Smiths Medical ASD Inc.	II	Apr-21-2021
5	Smiths Medical Asd Inc	II	Jan-17-2024