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	154	154
Material Separation	134	134
Disconnection	66	66
Break	60	60
Incorrect, Inadequate or Imprecise Result or Readings	42	42
Air/Gas in Device	30	30
Crack	29	29
Separation Failure	28	28
No Flow	26	26
Separation Problem	24	24
Inaccurate Information	23	23
Incorrect Measurement	21	21
Detachment of Device or Device Component	17	17
Unable to Obtain Readings	15	15
Leak/Splash	13	13
Pressure Problem	12	12
High Readings	12	12
Material Split, Cut or Torn	9	9
Device Sensing Problem	6	6
Material Integrity Problem	6	6
Device Markings/Labelling Problem	5	5
Reflux within Device	5	5
Obstruction of Flow	5	5
Device Contamination with Chemical or Other Material	4	4
Output Problem	4	4
Failure to Zero	4	4
Connection Problem	4	4
Backflow	4	4
Difficult to Flush	3	3
Inappropriate Waveform	3	3
Calibration Problem	3	3
Infusion or Flow Problem	3	3
Electrical /Electronic Property Problem	3	3
Mechanical Problem	3	3
Improper Flow or Infusion	3	3
Gas/Air Leak	3	3
Difficult to Insert	3	3
Inaccurate Delivery	2	2
Failure to Calibrate	2	2
Low Readings	2	2
Material Rupture	2	2
Fail-Safe Problem	2	2
Loose or Intermittent Connection	2	2
Contamination	2	2
Defective Device	2	2
Device Displays Incorrect Message	2	2
Deformation Due to Compressive Stress	2	2
Incomplete or Inadequate Connection	2	2
Material Puncture/Hole	2	2
Loss of or Failure to Bond	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	624	624
Hemorrhage/Bleeding	42	42
Insufficient Information	28	28
No Consequences Or Impact To Patient	20	20
No Known Impact Or Consequence To Patient	8	8
No Patient Involvement	8	8
Blood Loss	6	6
Death	3	3
Low Blood Pressure/ Hypotension	3	3
Air Embolism	2	2
Thrombosis/Thrombus	2	2
Discomfort	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Chemical Exposure	1	1
Cardiac Arrest	1	1
Burn(s)	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
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	Smiths Medical ASD Inc.	II	Apr-21-2021
4	Smiths Medical Asd Inc	II	Jan-17-2024